Wadding, Gauze, Bandages and Similar Articles of Heading 3005

Published CBP guidance; operative status and applicability must be assessed from the retained publisher edition.

What Every Member of the
Trade Community Should Know About:

Wadding, Gauze,
Bandages and
Similar Articles
(Heading 3005
HTSUS)

AN INFORMED COMPLIANCE PUBLICATION
JULY 2006

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July 2006

NOTICE:
This publication is intended to provide guidance and information to the trade community.
It reflects the position on or interpretation of the applicable laws or regulations by U.S.
Customs and Border Protection (CBP) as of the date of publication, which is shown on
the front cover. It does not in any way replace or supersede those laws or regulations.
Only the latest official version of the laws or regulations is authoritative.

Publication History

First Issued April 2000
Reviewed with no changes January 2004
Revised July 2006

PRINTING NOTE:
This publication was designed for electronic distribution via the CBP website
(http://www.cbp.gov/) and is being distributed in a variety of formats. It was originally set
up in Microsoft Word97
®
. Pagination and margins in downloaded versions may vary
depending upon which word processor or printer you use. If you wish to maintain the
original settings, you may wish to download the .pdf version, which can then be printed
using the freely available Adobe Acrobat Reader
®
.

Wadding, Gauze, Bandages and Similar Articles
July 2006

PREFACE

On December 8, 1993, Title VI of the North American Free Trade Agreement Implementation
Act (Pub. L. 103-182, 107 Stat. 2057), also known as the Customs Modernization or “Mod” Act,
became effective. These provisions amended many sections of the Tariff Act of 1930 and
related laws.

Two new concepts that emerge from the Mod Act are “informed compliance” and “shared
responsibility,” which are premised on the idea that in order to maximize voluntary compliance
with laws and regulations of U.S. Customs and Border Protection, the trade community needs to
be clearly and completely informed of its legal obligations. Accordingly, the Mod Act imposes a
greater obligation on CBP to provide the public with improved information concerning the trade
community's rights and responsibilities under customs regulations and related laws. In addition,
both the trade and U.S. Customs and Border Protection share responsibility for carrying out
these requirements. For example, under Section 484 of the Tariff Act, as amended (19 U.S.C.
1484), the importer of record is responsible for using reasonable care to enter, classify and
determine the value of imported merchandise and to provide any other information necessary to
enable U.S. Customs and Border Protection to properly assess duties, collect accurate
statistics, and determine whether other applicable legal requirements, if any, have been met.
CBP is then responsible for fixing the final classification and value of the merchandise. An
importer of record’s failure to exercise reasonable care could delay release of the merchandise
and, in some cases, could result in the imposition of penalties.

The Office of Regulations and Rulings (ORR) has been given a major role in meeting the
informed compliance responsibilities of U.S. Customs and Border Protection. In order to
provide information to the public, CBP has issued a series of informed compliance publications
on new or revised requirements, regulations or procedures, and a variety of classification and
valuation issues.

This publication, prepared by the National Commodity Specialist Division, ORR, covers
wadding, gauze, bandages and similar articles of heading 3005. “Wadding, Gauze, Bandages
and Similar Articles (Heading 3005 HTSUS)” provides guidance regarding the classification of
imported merchandise*. We sincerely hope that this material, together with seminars and
increased access to rulings of U.S. Customs and Border Protection, will help the trade
community to improve voluntary compliance with customs laws and to understand the relevant
administrative processes.

The material in this publication is provided for general information purposes only. Because
many complicated factors can be involved in customs issues, an importer may wish to obtain a
ruling under Regulations of U.S. Customs and Border Protection, 19 C.F.R. Part 177, or to
obtain advice from an expert who specializes in customs matters, for example, a licensed
customs broker, attorney or consultant.

Comments and suggestions are welcomed and should be addressed to the Assistant
Commissioner at the Office of Regulations and Rulings, U.S. Customs and Border Protection,
1300 Pennsylvania Avenue, (Mint Annex) NW, Washington, D.C. 20229.

Sandra L. Bell,
Acting Assistant Commissioner
Office of Regulations and Rulings

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INTRODUCTION.......................................................................................... 7
DEFINITIONS AND USES........................................................................... 8
MATERIALS.............................................................................................. 11
PHARMACEUTICAL SUBSTANCES....................................................... 13
RETAIL PACKAGING, LABELING, FOLDING......................................... 16
POST-IMPORTATION MANIPULATIONS................................................ 18
PRODUCTS OUTSIDE THE PURVIEW OF HEADING 3005.................... 20
POSSIBLE MISCLASSIFICATION CONSEQUENCES............................ 24
THE IMPORTER’S RESPONSIBILITIES.................................................. 25
INVOICE REQUIREMENTS...................................................................... 25
ADDITIONAL INFORMATION................................................................... 27
The Internet............................................................................................................................... 27
Customs Regulations................................................................................................................ 27
CBP Bulletin............................................................................................................................. 27
Importing Into the United States............................................................................................... 28
Informed Compliance Publications........................................................................................... 28
Value Publications.................................................................................................................... 29
“Your Comments are Important”.............................................................................................. 30

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INTRODUCTION

Heading 3005 of the Harmonized Tariff Schedule (HTS) appears straightforward
enough at first glance. It provides for “[w]adding, gauze, bandages and similar articles
(for example dressings, adhesive plasters, poultices) impregnated or coated with
pharmaceutical substances or put up in forms or packings for retail sale for medical,
surgical, dental or veterinary purposes.” All products classifiable in the provisions of the
heading are statutorily free. We use adhesive bandages (e.g., Band-Aids®) in our
homes. We have seen bandages of all types in pharmacies, gauze pads used by our
physicians, and cotton wadding used by our dentists. It is all seemingly simple
merchandise and all free of duty. Yet this has been an area of some difficulty. Brokers
and importers classify many items in heading 3005 that do not belong there. As we
shall see, the primary factors to consider for product classification in this heading are
purpose (medical use - wound treatment), presence of pharmaceutical substances, and
packing. This is important because failure of a product to meet the criteria required by
the language of the heading may result in classification discrepancies, duty liability, and
possible quota consequences.

Heading 3005 is divided into two subheadings: subheading 3005.10, which
encompasses adhesive products, and subheading 3005.90, which encompasses
nonadhesive products. Within each of those two subheadings a distinction is made
between products coated or impregnated with pharmaceutical substances (i.e.,
subheadings 3005.10.1000 and 3005.90.1000) and products not coated or impregnated
(i.e., subheadings 3005.10.5000 and 3005.90.50). That is the easy part! The difficulty is
in understanding the parameters established by the language of heading 3005.

Since classification is initially determined according to the terms of the HTS headings,
pursuant to Rule 1 of the General Rules of Interpretation, HTS, we must give close
attention to the overall descriptive language of heading 3005. The first part of the
heading speaks of wadding, gauze, bandages and “similar articles” such as dressings,
adhesive plasters, and poultices. The concept of “similar articles” is subject to the rule
of ejusdem generis (of the same kind or class). Similar goods are limited to those which
“possess the essential characteristics or purposes that unite the articles enumerated eo
nomine” [Totes, Inc. v. U.S., 69 F.3d 495, 498 (Fed. Cir. 1995)].

Merchandise of heading 3005 is, first of all, wadding, gauze, bandages, dressings,
adhesive plasters, poultices and the like. The second part of the heading then provides
exact and limiting language for inclusion in the heading. Products must also be either
coated or impregnated with pharmaceutical substances, or put up in forms or packings
for retail sale. Additionally, in either case, articles of heading 3005 must be for medical,
surgical, dental or veterinary purposes. These are the essential characteristics or
purposes required of such products for classification in heading 3005.

It is our intention to first examine the general nature of the articles enumerated in
heading 3005 and then look at the limiting language. We will provide definitions and
examples of the exemplars and try to find their shared characteristics. We will then

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discuss pharmaceutical coating and impregnation. Products treated with such
substances will almost always be classifiable in heading 3005, so it is important to have
an idea of what is meant by them. We will discuss products which are not coated or
impregnated and examine what types of characteristics (e.g., folding, labeling,
packaging, etc.) may be encountered in such products. We will then look at CBP policy
regarding allowable and non-allowable manipulations of “bandage-like” products after
importation. Finally, we will provide examples of products often misclassified in the
heading, and end with an overview of the possible consequences of misclassification.

DEFINITIONS AND USES

If we consult any medical dictionary, we find that all the examples given in the
legal text of the heading, namely: bandages, wadding, gauze, dressings, adhesive
plasters, poultices, etc., share the characteristic of being directly applicable to
diseased or injured body tissue. This is reflected in the legal language of heading
3005, as well as in the Explanatory Notes (EN) to the heading, which constitute the
official interpretation to the tariff at the international level. Thus, the guiding principle
is that the enumerated products are limited to materials used in the treatment of
wounds in a medical, surgical, dental or veterinary setting. We will now examine
some common commercial conceptions of such articles.

Wadding is defined in the PDR® Medical Dictionary, First Edition as “[c]arded cotton or
wool in sheets, used for surgical dressings. ” Gauze is a “bleached cotton cloth of plain
weave, used for dressings, bandages, and absorbent sponges” (PDR® Dictionary).
Surgical gauze or absorbent gauze USP must meet certain standards of purity, thread
count, construction and sterility as described in the monograph on absorbent gauze in
the United States Pharmacopeia.

Wadding and gauze are thus general terms for materials used for surgical or wound
dressings. These basic materials are often classified by their mesh (number of threads
per inch), fiber length (for tensile strength), weight (in grams per square meter), or
absorbency as required by a specific application. For example, some types of surgical
dressings may require a closely woven gauze for extra strength or greater protection,
while other wound dressings may require a more open weave for better absorbency or
drainage.

Many products of heading 3005 are made of these cotton-based materials alone.
Others are composite articles of cotton with other materials (such as plastic-film
coatings or synthetic fibers such as Dacron or rayon). Others are made completely of
other materials such as oxidized cellulose (sterile gauze or cotton which has been
chemically treated to make it hemostatic and absorbable), dried animal skin tissue,
plastics such as vinyl copolymers, methacrylics, polyesters or rayons. Still others are
impregnated or coated with pharmaceutical materials (such as petrolatum or oil/water
emulsion) to render them less adherent to open wound surfaces. There are even liquid
dressings, usually made of plastics in a solvent, which are sprayed onto the injured

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tissue area covering wounds with a protective film. The development of various types of
wound treatment products reflects the need to have products available that afford the
greatest amount of protection and absorption while minimizing discomfort of the patient.

Like wadding and gauze, dressing is also a general term. We find that Stedman’s
Medical Dictionary, 27th Edition (Stedman’s), defines dressings as “the material
applied...to a wound for protection, absorbance, drainage, etc.” In Dorland’s Illustrated
Medical Dictionary, 29th Edition (Dorland’s), dressings are described as “any of various
materials utilized for covering and protecting a wound.” Remington: The Science and
Practice of Pharmacy 20th Edition (Remington’s) defines surgical dressing as a term
applied to a range of materials used for the dressing of wounds. There are various
classes of dressings such as primary wound dressings, absorbents, bandages, surgical
adhesive tapes and protectives. The following discussion is based on the discussion in
Remington’s found in the chapter on surgical supplies.

Primary wound dressings are applied directly to wound surfaces to help absorb the
wound secretion and minimize maceration (unwanted softening of the tissue). Plain
gauze compresses are rarely used nowadays because of their tendency to adhere to
the wound. Specialized products have been developed which have a low degree of
adherence. Stretchable cellulose with an oil/water emulsion is used for all types of
wounds such as burns, skin grafts and open ulcers. Pads covered with soft plastic film
having openings allow fluids to pass through while eliminating adhesion to the wound.
Transparent films are not only nonadherent, but allow for examination of the wound
without removal of the dressing.

Absorbents include open-mesh gauzes and surgical sponges made of nonwoven
synthetic fabrics. These are more lint-free and more absorbent than cotton gauze
sponges. Gauze strips with ravelproof edges that eliminate all loose threads are ideal
for use as packing strips in nose and sinus surgery as well as drainage wicks in the
treatment of draining wounds such as boils and abscesses. Folded surgical pads or
sponges, which may be unfolded to larger sizes without exposing cut edges or loose
threads, are a standard part of operating room tray sets. Laparotomy sponges are used
in surgical procedures to prevent abdominal or other organs from entering the field of
operation. They are made of four layers of gauze, with the edges folded in and
hemmed.

Bandages are “...piece[s] of cloth or other material, of varying shape and size, applied
to a body part to make compression, absorb drainage, prevent motion, retain surgical
dressings” (Stedman’s). The function of a bandage is to hold a dressing in place by
compression or support. Among the types of bandages available are rolls of absorbent
gauze or muslin in continuous pieces. They may be cut as required. Muslin bandages
are particularly strong and are used to hold bulky dressings or splints in place.
Conforming or clinging bandages are made of specially processed gauze folded to the
center. They conform to body parts and are self-clinging, thus preventing slippage.
They are also used to hold dressings and splints in place. High-bulk bandages are
made of up to six layers of crimped gauze and are designed to provide additional

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protective padding in wound dressing applications. Triangular bandages are used to
hold head dressings in place and can also be used in first-aid work as temporary splints
for broken bones. Surgical stockinette bandages are made of stockinette material (an
elastic, machine-made cloth) knitted or woven in tubular form. Their stretchability allows
conformity to the arm, leg or body. They are used to cover and protect the skin prior to
the application of a hard cast. These are typically sold in large rolls and cut to length as
needed by a health care provider. Cast paddings are also applied to the skin under a
cast to provide moisture absorption and allow the skin to breathe. Plaster coated
fracture bandages must be included here as well, provided they are put up for retail sale
for medical purposes (EN, heading 3005, p. 574).

Adhesive tapes are also included in heading 3005, provided they are impregnated or
coated with pharmaceutical substances or are put up in forms or packings for retail sale
for medical, surgical, dental or veterinary purposes [EN exclusionary item (a) to heading
5906, p. 1035]. In such applications they are generally used to retain dressings. The
primary concern in the use of such tapes is that they be hypoallergenic and
nonocclusive, allowing the passage of excessive moisture away from the skin.

Protectives are used in conjunction with dressing materials to prevent loss of moisture
or heat from a wound site. Film dressings are acrylate adhesives on a transparent,
vapor- permeable plastic film applied directly to a wound surface. They are impervious
to water and bacteria and are used to dress wounds which are already healing.

Stedman’s and Remington’s characterize plasters, or adhesive plasters, as solid
preparations which can be spread when heated, and which become adhesive at the
temperature of the body. They are used to keep wound edges in apposition, protect
raw surfaces, and, when medicated, to redden or blister the skin (this is a counterirritant
action to relieve symptoms of a deeper inflammation), or to apply drugs to a desired
location.

Poultices are described as soft, moist masses prepared by wetting various powders or
other absorbent substances with watery or oily fluids. They are sometimes medicated,
and usually applied hot to the surface to create moist local heat or counterirritation. The
classic poultices were spread on muslin, linen or other material. They were used to
localize infectious material, and, when medicated, to supply a counterirritant effect, or
exert an emollient effect upon a sore or inflamed part of the body by local application to
the skin and underlying tissue surrounding the inflammation or sore (Remington’s,
Stedman’s, Oxford English Dictionary, 2nd Ed.).

Compresses may be considered to be products similar to those enumerated in heading
3005. The Oxford English Dictionary defines a compress as follows: “[a] soft mass of
linen, lint or other material formed into a pad, which by the aid of a bandage, can be
made to press upon any part; used for compressing an artery, for keeping a dressing,
plaister (sic), etc., in place, applying medical agents, and the like.” Webster’s Third New
International Dictionary Unabridged offers two definitions of a compress: 1) “a covering
consisting usu. of a folded cloth that is applied and held firmly by the aid of a bandage

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over a wound dressing to prevent oozing;” 2) “a folded wet or dry cloth applied firmly to
a part (as to allay inflammation).” The Random House Unabridged Dictionary, 2nd Ed.,
describes a compress as “a soft, cloth pad held in place by a bandage and used to
provide pressure or to supply moisture, cold, heat, or medication.” To be classifiable in
heading 3005, a compress would have to be used in wound treatment, as, for example,
a compression product used to treat venous ulcers. In such case, the compression
serves to keep apposing wound edges together. Another example would be a gauze
compress used as a primary wound dressing to absorb moisture, apply medication, etc.

Certain products provide support by compression for strained or sprained body parts
(e.g., thoracic supports, hernia belts, elastic supports for wrists, knees and elbows,
etc.). Other products serve to alleviate pain or reduce swelling by the delivery of heat or
cold (e.g., heating pads, ice bags, eye masks, hot water bottles, etc.). While such
articles may have application in medical or first-aid settings, they do not have the
characteristics of the products of heading 3005, since they are not used in wound
treatment. For a more complete discussion of compression products and articles used
to deliver heat and cold, see the section entitled “Products Outside the Purview of
Heading 3005.”

It appears clear from the foregoing definitions and concepts that the examples
provided in the language of heading 3005 serve specialized functions in the field
of health care. These functions are characterized by direct application to
diseased or injured tissue, e.g., application to wounds for protection,
immobilization, medication, etc. This is borne out by the definitions presented
above. Products serving a lesser or different purpose, such as cleansing or
soothing uninjured skin, are not classifiable in heading 3005. The basic
requirement is that all these products must be for wound treatment in a medical,
surgical, dental or veterinary setting, whether impregnated or coated with
pharmaceuticals, or labeled, folded and packed for retail sale.

MATERIALS

The products defined above are basic, first-line materials used in the management of
wounds. We will now focus on some of the materials making up these products. As we
will see, different materials provide particular physical characteristics chosen for specific
wound treatment and management needs.

The EN to heading 3005, p. 573, enumerate textiles, paper and plastic as examples of
some of the materials encountered in products of that heading. In addition, the EN also
include such specialty products as “cutaneous dressings,” comprised of dried animal
skin tissue put up in sterile containers labeled with instructions for use, and “liquid
dressings,” comprised of solutions of synthetic polymers with a propellant put up for
retail sale in aerosol spray cans. There are dozens of wound care products on the
market in the United States. We will look at some types and attempt to describe their
specialized functions. The physician, clinician, dentist, veterinarian or first-aid giver will

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select a particular product on the basis of the cause (e.g., burn, impact, cut), severity
and location of the wound. Other products are utilized in more complicated
applications, such as in skin graft or surgical procedures where immediate and rapid
wound drainage, warmth, wound isolation, or surgical wall or organ protection may be of
paramount importance.

Generally speaking, dressings are designed to optimize the immediate environment by
providing a number of physical characteristics conducive to wound healing and
maintenance. Depending on the severity of the wound, a dressing should provide a
combination of any of the following characteristics: absorption or drainage of any wound
exudate, occlusion to maintain a certain level of moisture (this has been found to help
prevent later scarring), hydration to provide moisture, insulation to keep the wound
warm and protect it from infectious agents, protection from physical harm, easy
applicability and clean removal, odor reduction, wound visibility, etc.

The various available materials, sometimes in combination with topical pharmaceutical
substances (see next section), must be chosen carefully by the clinician, physician,
nurse, first-aid giver, etc., based on the extent and condition of the wound being treated.
The following will provide some of the aforementioned qualities; all have certain
advantages and disadvantages. We are listing them here with no intent of training the
importer in wound treatment:

Gauzes: As previously noted, many bandage and dressing products are made of
gauze. It affords many advantages, such as absorbability, good drainage, and easy use
with topical pharmaceuticals and conformability. It has the disadvantage of needing
frequent changing and sometimes “shedding” and adhering to the wound.

Foams: Foam dressings are made of nonadhesive polyurethane material. Products
made of this material are absorptive, provide thermal insulation, maintain moisture,
need to be changed less frequently, and are easy to remove without trauma. They are
used in shallow wound treatment. They are not designed for deep wound or third-
degree burn treatment.

Gels: Hydrogel dressings consisting of up to 95% water in sheets or gel forms are
nonadherent, nonocclusive products with a high moisture content. They are used in
treatment of wounds which have already begun to heal (with little exudate). They carry
exudate away from the wound but retain it to provide a moist environment. They have
advantages such as conformability, thermal insulation and easy removal. Gauze
dressings are often impregnated with hydrogels.

Dextranomer: Dextran polymers specially prepared in small beads and available in unit
dose packs are used to absorb dead tissue from around a secreting wound (such action
is referred to as non-surgical debridement). Dextran beads are also poured over a
wound to absorb exudate and prevent crust formation.

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Films: Translucent dressings made of synthetic plastic materials help retain exudate
over the wound, and are highly protective because they are impermeable to water and
bacteria. A great advantage of this type of dressing is that the wound can be observed
without constant dressing changes. Some special products even have a grid printed on
the film so that the wound’s progress can be monitored.

Alginates: Hydrophilic non-woven dressings are made of calcium or sodium alginate
fibers. Alginates are derived from seaweed. Alginate dressing fibers are transformed
into gel by wound exudate. These are useful in deep wound applications. They are
absorptive, conformable, maintain a moist environment and are easily removed.
Alginate dressings should not be confused with surgical or dental hemostats made of
calcium alginate. Those are used in surgical procedures to stop bleeding and are
eventually absorbed by the body (classifiable in heading 3006.10, HTS).

Hydrocolloids: These are composed of various natural (e.g., agar), semisynthetic (e.g.,
modified cellulose) or synthetic (e.g., polyvinylpyrolidone) materials. They are often in
wafer form, with the hydrocolloidal particles contained in an adhesive form covered by a
watertight film. These are used for all but the most severe wounds. They maintain
exudate by particle swelling, maintain moisture, are impermeable to water and bacteria,
provide thermal insulation, and provide immediate pain relief.

This is a list of some of the more common products. It is not intended to be all inclusive.
There are many other materials utilized. Whatever the material, it must be clear that the
product be exclusively intended for medical uses, and be either impregnated or coated
with pharmaceutical substances, or be in forms or packings for retail sale for use by the
end-user.

PHARMACEUTICAL SUBSTANCES

Once it has been determined that a product has medical, surgical, dental or veterinary
use, the next question is whether or not it is impregnated or coated with a
pharmaceutical substance. Often a dressing or other product of heading 3005 will be
coated or impregnated with a substance that provides additional chemical or physical
characteristics important to the management of a wound. Such treatment may be
considered a de facto indication that certain products are intended for medical uses.
Therefore, the text of heading 3005 does not require that impregnated or coated
products be packed or folded in any particular way. However, when considering such
products, the importer must be aware that the mere presence of a pharmaceutical
substance does not necessarily mean that the product is impregnated or coated with
that particular material. For example, a barium sulfate radiopaque monofilament sewn
or woven into a laparotomy sponge or a surgical towel is not considered an
impregnation or a coating. The product must actually be physically impregnated or
coated with the pharmaceutical substance. [HQ 952369 of 12/17/93, HQ 956806 of
11/1/94 and NY 885010 of 5/4/93.]

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There is no clear definition of the term “pharmaceutical substances” in the HTS or in the
EN. A few examples are given in the EN: counterirritants and antiseptics (EN to
heading 3005, p. 573), and antibiotics (EN to heading 3802, p. 672). General Note 13
to the HTS, which addresses the use of the Pharmaceutical Appendix to the Tariff
Schedule, refers to pharmaceutical products listed in the Appendix as drugs. The EN to
heading 1211, p. 97, comes the closest to defining “pharmacy” for HTS purposes by
stating that “...the broader term ‘pharmacy’ has reference both to medicaments and to
products having no therapeutic or prophylactic uses...”

In dealing with heading 3005, CBP allows a broad concept of pharmaceutical
substances. Therapeutic products such as drugs, as well as non-therapeutic
substances such as water and oil emulsions, qualify as pharmaceutical substances. As
long as the products of heading 3005 are impregnated or coated with these types of
substances, they will be classifiable in subheadings 3005.10.10 or 3005.90.10. No
other folding or packing will be required in such cases, but for the two exceptions
described in the EN to heading 3005, namely: products covered with zinc oxide and
plaster-coated fracture bandages. Such products must be packed for retail sale to be
classifiable in heading 3005 (EN, p. 574). Otherwise, impregnated or coated products
do not have to be packed or folded or labeled in any particular way as long as they are
used for medical, surgical, dental or veterinary purposes.”

There are numerous pharmaceutical products found in bandage and dressing-like
products of heading 3005. Generally, such substances will perform a subordinate, but
necessary, function in the product’s application to the wound. Sometimes the function
of the pharmaceutical will be of paramount importance. Pharmaceutical substances
may assist in protecting tissue or alleviating tissue irritation (e.g., oil/water emulsions,
ointments, demulcents, humectants, emollients, astringents, counterirritants, etc.),
provide extra absorbency for wound drainage or keeping skin free of excess moisture
during healing (absorbents, protectives), provide antiseptic action for the immediate
wound area (iodoform, povidone-iodine, isopropyl alcohol, antibiotics), alleviate or
manage pain (local anesthetics, corticosteroids), deodorize the wound area (activated
charcoal), act as non-surgical debriders to clear away dead tissue during healing
(enzymes), etc.

In all probability, the most common type of pharmaceutical substance with which
dressing or bandage materials are impregnated or coated is the antiseptic. This would
include inter alia iodoform, povidone-iodine, iodine, bactine, benzalkonium chloride,
silver sulfadiazine, hexylresorcinol, salicylic acid, 1% glacial acetic acid solution,
bismuth tribromophenate, 8-hydroxyquinoline, diluted acetic acid, isopropyl alcohol, and
ethanol. The last two products have mild antiseptic actions at 70% concentrations and
higher. If a product containing these alcohols were indicated merely for cleansing
unbroken skin, that product would not be considered classifiable in heading 3005. [HQ
953256 of 6/9/93.] Generally, antiseptics would be used to enhance the protective
quality of a dressing by further reducing the bacteria count at a wound site.

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Antibiotics would serve a purpose similar to that of antiseptics. The topical use of
antibiotics for bacterial count reduction in wound treatment is limited to non-systemic
antibiotics such as polymixin B, bacitracin, neomycin, gramicidin, and nystatin. They
are often formulated with other pharmaceuticals such as hormones and local
anesthetics in combination creams, ointments and powders.

Topical agents include substances that act physically as well as chemically on skin
tissue. Such products work in various ways to insulate or protect the skin from external
factors (bacteria etc.), provide absorbency, provide mechanical support, act as carriers
for medicaments, alleviate irritation, act as counterirritants, soften and/or moisturize the
skin, etc. Such agents include protectives, such as zinc gelatin and white petrolatum;
absorbent-moisturizers, such as hydrogels; adsorbents, such as kaolin; odor
absorbents, such as carbon; astringents, such as aluminum acetate topical solution and
zinc oxide; local anesthetics, such as lidocaine; keratolytics, such as salicylic acid
(which is also antiseptic); chemical debriders, such as enzymes and dextran polymer;
and various ointment bases, such as oil/water emulsions, polyethylene glycol ointment,
etc., which are designed to act both as emollients and drug delivery facilitators.

More often than not, the foregoing products would be separately applied to a wound
area and then covered by a dressing and/or bandage product. However, there are
numerous products on the market which are impregnated or coated with such materials.
A dressing product intended for use in the medical, surgical, dental or veterinary fields
will most likely not contain anything but a “pharmaceutical substance” which meets the
requirements of the United States Pharmacopeia (USP). It should also be noted that
these types of products are designed for local application, treating only the immediately
injured or diseased tissue.

There is a group of products called transdermal delivery systems that are designed
for the systemic delivery of drugs. Such products are not classifiable in heading 3005.
Transdermal delivery systems are differentiated from products of heading 3005 in a
number of ways. They may appear at first glance to resemble adhesive patches
containing a medicament, but are actually more highly engineered. They often consist
of a backing, a well or reservoir containing a drug substance, which is released in a
timed fashion through a properly chosen control membrane, an adhesive layer, and a
protective layer. The intent is to deliver the drug through the vascular system of the skin
to the desired internal organ. The result is that the drug is treating a condition
systemically, rather than locally. A transdermal system may be applied anywhere on
the body. Products of heading 3005, as we have seen, are applied locally for local
action.

Examples of transdermal systems are nitroglycerin (for the treatment of angina) in disks
applied to the upper chest or arm, scopolamine (for the treatment of nausea) applied
behind the ear in a polymer device, clonidine (an antihypertensive drug) in a
multilayered film, and estradiol (to treat various symptoms and conditions associated
with menopause) in a multilayered system. [See HQ 961177 and HQ 961666, both of
4/14/98, as well as World Customs Organization, Harmonized System Committee, 22
nd

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Session, November, 1998, classification decision.] All of these products are classifiable
as measured dosage forms of medicaments in various subheadings of heading 3004,
HTS, not in heading 3005. However, patches containing chemical contraceptives are
classifiable in subheading 3006.60.0000 by virtue of HTS Chapter 30 Note 4(h).

RETAIL PACKAGING, LABELING, FOLDING

When describing wadding and gauze for dressings and bandages not impregnated or
coated with pharmaceutical substances, the EN to heading 3005 speak of labels affixed
or special folding as being indicative of intended use for surgical, medical, dental, or
veterinary purposes (EN, p. 573). The heading language and EN (p. 573) also state, as
we have seen, that such products must be for direct sale, without repacking, to users
(private persons, hospitals, etc.). In this section, we will survey some of the typical
labels, folding and packages often encountered in these products. In the next section
we will look more closely at post-importation manipulations.

The Federal Food, Drug, and Cosmetic Act (FFDCA) and amendments thereto
designates the United States Pharmacopeia (USP) and the National Formulary (NF) as
official compendia for drug and pharmaceutical products in the United States. The law
recognizes USP and NF standards as guidelines for determining the identity, strength,
quality and purity of the articles. These standards also establish specifications for
labeling and packaging. In addition to the legal recognition, USP and NF standards play
an important role in ordinary industry and commercial transactions.

Surgical and medical dressings and related products must generally meet the
requirements of the USP for a number of specific characteristics, namely: material
content, absorbency, fiber length and width, weight, thread count, solubility, adhesive
strength, tensile strength, ignited residue, acidity or alkalinity, fatty matter, alcohol
soluble dyes, sterility, labeling, packaging and storage. Some of these requirements
may be stated on labels affixed to these products. The presence of such labels is one
of the indications the CBP officer or importer may rely on in determining the proper
classification of such articles.

The USP monographs on dressings and bandages have specific language concerning
thread count, layers, labeling and packaging. For example, the USP monograph
regarding the labeling of absorbent gauze states: “Its type or thread count, length, and
width, and the number of pieces contained, are stated on the container, and the
designation ‘non-sterilized’ or ‘not sterilized’ appears prominently thereon unless the
Gauze has been rendered sterile, in which case it may be labeled to indicate that it is
sterile. The package label of sterile Gauze indicates that the contents may not be
sterile if the package bears evidence of damage or has been previously opened.” The
labeling requirements are similar for many such products. Sterile products should be
marked as such and packaged in such a way as to maintain sterility. A typical USP
monograph will state as much. For example, the monograph on absorbable gelatin film

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reads as follows: “Preserve in a hermetically sealed or other suitable container in such a
manner that the sterility of the product is maintained until the product is opened for use.”

Many products are folded to provide ease of use or specialized application. Surgical
gauze pads or sponges are folded so that no cut edges are exposed. They are further
folded so that a smaller size pad may be opened to a larger size without exposing any
cut edge or loose threads. This helps reduce shedding or fraying and adhesion to the
wound. The pad or sponge or dressing may be available in various layers (e.g., 8-, 12-,
16-, 24-ply) for specific jobs. Laparotomy sponges are usually 4 layers of 28x24 mesh
gauze, folded toward the center and hemmed. Conforming bandages are made of
2-ply, high quality, 14x8 cotton gauze, folded toward the middle.

The lesson to be learned from such examples is that products of heading 3005 will often
clearly be designed, labeled, folded, packed, and sterilized for direct medical uses.
Folding, labeling and sterilization are not requirements, just illustrative of certain
intended applications. Definite use for medical purposes may be established by the
presence of accompanying literature, labeling, presentation, sterilization, protective
coverings, and instructions for use and storage. Such factors, though not compulsory or
decisive, may help establish exclusive intent for use for medical purposes, and for direct
sale to end-users.

Products not clearly packaged, labeled or folded for direct medical use may or may not
be classifiable in the heading. The intended use and the intended end-user must be
established and identified. Furthermore, in the context of the EN to heading 3005,
“retail” sale is not limited to sales by retailers, only to retail customers or users; it means
sales directly- without repacking- to end-users, whether individuals or institutions such
as hospitals (EN, p. 573).

CBP Headquarters, in HQ 953499 of 4/6/93, held that cotton bandage rolls sold to
hospitals and nursing homes in cartons of 100 were classifiable in heading 3005. In this
case, the importer declared there was no intention of repacking the bandages and that
the medical institutions used the bandages in such quantities as to justify bulk
purchases. By establishing the bulk sale to be for direct use by the hospital (i.e., the
end-user), and that no repacking would take place after importation, the importer was
able to satisfy the conditions required by the legal language of and the EN to heading
3005.

Imported materials, such as continuous rolls of wadding or gauze fabric in the piece,
manufactured into bandage or dressing products and then packed for retail sale
subsequent to importation are not classifiable in heading 3005. In such instances, since
such products lack the characteristics enumerated above (i.e., retail packing, cutting,
special folding or labeling), there would be no evidence to establish that they are, in
fact, “exclusively intended. . . for sale directly without re-packing to end-users. . . for use
for medical, surgical, dental or veterinary purposes” (EN, p. 573). Classification of such
products would then be based on the actual composition of the material. Possible

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classifications outside of heading 3005 will be briefly discussed in the section below
entitled “Possible Misclassification Consequences.”

POST-IMPORTATION MANIPULATIONS

As we have seen in the preceding section, when dealing with products not impregnated
or coated with pharmaceutical substances, there are usually indicators present, e.g.,
packing, folding, labeling, etc., which may help establish compliance with the
requirement for direct sale without repacking to the end-user for exclusive medical,
surgical, dental or veterinary use. Such indicators must be present in the products
in their condition as imported. Manipulations after importation, such as
repacking, labeling or relabeling, special folding, etc., will render the products
ineligible for classification in heading 3005. This principle is enunciated in the EN,
p. 573: repacking for retail sale after importation is not allowed, no matter what other
manipulation takes place. This is an extension of the legal language of the heading,
which requires that products of heading 3005, which are not impregnated or coated with
pharmaceutical substances, be “put up in forms or packings for retail sale for medical,
surgical, dental or veterinary purposes.” First of all, to be classified in heading 3005,
these articles must be imported in retail packing and be exclusively intended for direct
sale to end-users. Second, such articles must be specifically intended for medical
purposes. We have seen that labels, folding, accompanying instructions, and
sometimes sterilization may be indicative of medical use. If such indicators are not
there, or if they are added after importation, classification in heading 3005 may be
precluded.

With regard to heading 3005, the concept of repacking is most critical. CBP
Headquarters has been consistent and clear in its position: an imported product that is
neither impregnated nor coated with a pharmaceutical substance must be packed in a
manner requiring no further specialized packing for retail sale.

In HQ 959053 of 11/19/96, we find that a product imported in bulk and then repacked or
put up in a different form or package for retail, is not classifiable in heading 3005. In
that ruling, laparotomy sponges were imported already cut to size, sewn to specific
dimensions, and bundled together in packs of five with a paper band. Each sponge
contained an x-ray detectable strip (treated with barium sulfate) which was sewn into
the sponge. After importation, the importer shipped the sponges to two offsite pre-
sterilization plants. The pre-sterilization was accomplished by either gamma radiation
or steaming, without the sponges being removed from the original shipping cartons.
The cartons were then returned to the importer. After this pre-sterilization process, the
importer removed all the sponge bundles from the shipping cartons and encased them
in either a two-piece sealed pouch or two-piece sealed plastic tray. The pouches and
trays were labeled with the required label information. The importer stated that the
repacking into pouches and trays was strictly for final sterilization purposes. The
encased products were then placed in outer, gas-permeable, shipping cartons for final
sterilization. The final sterilization process was not described. The importer claimed

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that, during all this processing, the sponges were never removed from the fivepack
bundles and never refolded or otherwise changed. The importer held that the original
folding and bundling were sufficient to establish importation in a form for retail sale.

In disagreeing with the importer’s claims, CBP Headquarters emphasized that, despite
the presence of folding and bundling, the transfer of the sponges to trays or pouches is
a separate packing operation required before retail sale. The heading language
requires that products be put up in forms or packing for retail sale, i.e., already in retail
packaging ready for sale for medical uses. The EN further explains that that means the
products are not to be repacked before retail sale. “Forms for retail sale” does not refer
to special folding or the like. Folding by itself is only a possible indication of special
medical use. The requirement is for packaging, which clearly indicates intent for
medical uses at the retail or end-user level.

In HQ 952369 of 12/17/93, cotton gauze sponges specially folded, and containing
radiopaque strips, were banded together in bundles of ten and imported in bags
containing up to 4000 sponges. After importation, they were placed in trays with
foldover labels and sterilized. In this instance, CBP Headquarters ruled that, since the
sponges had to be repacked after importation before sale to the actual users, they were
not classifiable in heading 3005. Similarly, in HQ 956806 of 11/1/94, CBP Headquarters
ruled on laparotomy sponges folded and sewn around the edges, with an x-ray element
sewn in. The sponges were banded together in groups of five, labeled and placed in
cartons of 700 5-sponge packages. Subsequent to importation, the laparotomy
sponges were placed in plastic trays and sterilized. Once again, Headquarters
concluded that repackaging for sale to the end-users after importation precluded
classification in heading 3005.

The EN language is such that any repackaging for final retail sale prevents a given
product from being classified in 3005, even if that repackaging does not alter the
product itself in terms of physical characteristics such as size, weight, composition,
labels and folding. These characteristics may aid in determining whether or not a
product is intended for medical uses. By themselves they may indicate a certain
intention for use. However, the EN provides that the product still must be imported in
packages exclusively intended for such use for direct sale to the actual user. There can
be no intent to repack after importation. The importers’ customers must be considered
here. Are the customers end-users (private persons, physicians, hospitals, clinics),
retailers (drug stores), wholesalers, or repackers? If the customers are repackers, it
may indicate that there was no exclusive intent to sell directly to end-users without
repackaging. HQ 958285 of 11/22/96 addresses these issues in detail, although the
exact nature of the repackaging in that ruling is not articulated.

We have seen that a product imported in bulk, then unpacked, labeled and repacked
after importation, will not be classifiable in heading 3005, even if it is already in a
condition or form (e.g., folded and sewn) that would permit it to be shipped for direct
sale. If, before importation, a product is folded, sewn, equipped with an x-ray detection

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strip, bundled in groups, banded, overwrapped, placed in bags or trays, packed in
shipping cartons, and sterilized, it is classifiable in heading 3005 [HQ 085962 of 3/2/90].

CBPs’ position is one of strict interpretation of the EN, but it is limited to repacking or
significant manipulation of the immediate package. In other words, if an importer
imports a product already in a form or packing for retail sale (e.g., individually packed
and labeled gauze sponges), sterilizes it in that original packing and then packs it in a
different outer shipping carton, that product remains classifiable in heading 3005. The
product is already individually put up in an immediate container or packing for retail sale
and intended for medical use. In such a case, sterilization is merely a further indication
of the intended use of the product. [NY 853634 of 6/29/90 and HQ 959053 of 11/19/96.]
Products already put up in forms or packings for retail sale (e.g., a bandage roll packed
and labeled, Band-Aids® packed in their immediate retail packaging material) and
imported in shipping cartons, may be repacked into smaller shipping cartons and still be
classifiable in heading 3005. Breaking down shipping cartons of retail product into
smaller lots is not a significant repackaging operation. Such an operation would not
affect the immediate retail packaging of the product. The language of heading 3005
does not require that an importer sell only to a retail user, only that an imported
product be in a form or packing for retail sale for medical purposes. It is only
manipulations that require repackaging of the immediate retail package that are
not allowed.

PRODUCTS OUTSIDE THE PURVIEW OF HEADING 3005

Aside from the preceding post-importation manipulations, are there any other factors or
product characteristics that would preclude a given item from classification in heading
3005? In the section above on pharmaceutical substances, we discussed the
characteristics of transdermal drug delivery systems. We saw that those products were
not to be classified in heading 3005. In 1999, Customs and Border Protection revoked
a number of ruling letters issued on various other products previously classified in
heading 3005. These products also did not meet the requirements of the heading
language. As we have seen, products of this heading must be utilized in the various
aspects of wound treatment in a medical, surgical, dental or veterinary setting. Articles
not rising to the level of medical treatment are not classifiable in the heading.

Among the products previously classified in heading 3005 were bags of fabric filled with
various vegetable matter (cherry pits, flax seed, oatmeal, rice) and/or aromatic
components (lavender seeds, peppermint leaves). Also included were eye masks filled
with colored water and glycerol, magnetic “therapy” products (strips of adhesive tape
with magnets attached), huggable bunny rabbit pillows, cute frog pillows, and hot and
cold packs which could be frozen or heated. These products all offered some type of
stress relief, comfort from everyday woes, soothing relief from aches and pains, new
energy or vitality, or other tonic uses. Not one of them was intended for use in the
treatment of wounds in an actual medical setting. They were not of a class or kind of
product encompassed by the language of heading 3005. There were dozens of rulings

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in effect classifying such products in heading 3005 until 1999, when CBP Headquarters
issued and posted revocations in the CBP Bulletin on a number of them. In posting
those revocations, CBP Headquarters announced that the revocations covered any
rulings on similar merchandise that may exist but were not specifically identified.

The ruling letters discussed in the following paragraphs cover a wide range of products
no longer classifiable in heading 3005. Importers of substantially identical merchandise
should be guided accordingly.

HQ 962611 of 5/4/99 overturned NY A85858 of 6/25/96. The “SUPER BAN Massage
Patch” consisted of an adhesive patch on a release-paper backing. Each patch was
7/8” x 7/8”, had four ventilation holes, and contained a small, round ferrite magnet
attached at the center of the patch. The product was to be applied directly to the skin to
relieve “tightness” and to promote circulation in the local area. CBP Headquarters ruled
that such a product was not of a class or kind possessing the characteristic of articles
enumerated in heading 3005. Such articles must be directly applicable to an open
wound or irritated (e.g., by infection) skin. It was held that the heading is limited to
items used for actual medical purposes. The relief of tightness and circulation
improvement claimed to be provided by the “SUPER BAN” product did not rise to the
level of medical treatment. HQ 962612 of 5/4/99 overturned NY A83573 of 5/12/96.
The product in that ruling, “Magnetty 1000,” was a variation on the “SUPER BAN”
theme: a small magnet on an adhesive patch generated a magnetic field which
improved circulation, thus relieving pain, soreness or stiffness. Again, this product was
not used for wound treatment. Its pain relief claim did not rise to the level of medical
use. These goods were found to be composite articles classifiable in heading 8505
according to the component (the ferrite magnet) which gave them their essential
character (operation of General Rule of Interpretation 3(b)).

HQ 962352 of 2/11/99 modified NY 806312 of 2/16/95. In the New York ruling, “Cool
Paks” were classified in heading 3005. These were various sizes of rectangular pads
made of polyacrylamide crystals enclosed within woven fabric. When soaked in water,
the crystals absorb the liquid and expand to many times their original size. The pads
are then placed against the skin. The coolness of the absorbed water and the action of
evaporation of moisture from the skin bring about a cooling effect. Alternately, the
product may be warmed in a microwave oven and used to provide heat treatment to an
area of the body. In revoking this ruling, CBP Headquarters again found that the
product was intended to provide a degree of comfort, but was not of a kind used to treat
a wound. The intended use did not rise to the level of medical purposes. Final
classification, in heading 3926, was based on the component (the polyacrylamide
crystals) which imparted the essential character to the article.

HQ 962310 of 4/13/99 revoked NY B86429 of 6/23/97. A flaxseed eye mask,
“Sobakawa Pillow,” consisted of a small, sealed pouch of woven fabric filled with
flaxseeds. Accompanying instructions indicated that the product should be placed
across the bridge of the nose and over the eyes to soothe tired eyes. The product could
also be placed in a freezer prior to application. CBP Headquarters held that soothing

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the eyes was not a characteristic of products enumerated in heading 3005 and that the
tonic effect did not rise to the level of medical use.

HQ 961089 of 4/13/99 revoked NY A83830 of 5/31/96. “PitPacs” heating and cooling
pads consisted of cherry pits encased in a cotton bag. The instructional literature
indicated that these bags could be heated in a microwave oven, standard oven, or
double boiler, or cooled in a freezer. In the heated or cooled state the bags could be
applied to the body to reduce tension, aches and pains. This use was held to be of a
general tonic nature, and the product could not be considered to have a definable
medical purpose.

In HQ 962353 of 4/13/99, revoking NY 813748 of 8/14/95, a “Magic Bag” contained
cereal (oat) grains in a cotton bag. These bags were also designed to be heated or
cooled as instructed. They were to be used on the body to reduce swelling and relieve
aches and pains. This use was found not to be similar to that of products classifiable in
heading 3005. Reduction of aches and pains was also not considered a medical
application.

The “Sobakawa Pillow,” the “PitPacs,” and the “Magic Bag,” were all reclassified
according to the components imparting the essential character to the articles. In these
cases, those components were the vegetable products (flaxseed, cherry pits, and oats).
Classification was in heading 1404.

An importer of similar merchandise must be prepared to submit to CBP a compositional
breakdown by weight, as well as a material breakdown by value, of all the components
of the product. Additionally, samples and instruction for use should be made available
to the CBP officer examining the merchandise for classification.

We have seen that the preceding products not only do not belong to the same class or
kind of merchandise as heading 3005 exemplars, but that they also have no true
medical uses. However, there are other products intended for medical or first-aid
applications that nevertheless do not belong to the class or kind of merchandise
envisioned by the legal language of heading 3005. In the following paragraphs, we will
discuss compression products, triangular bandages, elastic bandages, and cotton
swabs. The intent is to examine if and how such products may differ from those of
heading 3005. Importers of such products should seek classification advice from
Customs and Border Protection. A full discussion of classifications outside of heading
3005 is not within the purview of this publication.

As a reminder, a bandage is essentially a piece of material applied to a body part to
make compression, absorb drainage, prevent motion, or retain surgical dressings. To
this medical dictionary definition we may add the concept of lending support to an
injured area [HQ 953990 of 8/2/93]. When does such a product remain classifiable in
heading 3005 and when does it not?

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In the previous section on “Definitions and Uses,” we mentioned tubular bandages,
made of stockinette material, and triangular bandages, which have a number of medical
uses, as being classifiable in heading 3005. Woven or knitted stockinette tubular
bandages are sometimes used as a protective covering for irritated skin before a cast is
applied to a broken limb. They are also used as compresses in the treatment of
edemas. When packaged for retail for such uses, these have been classified in heading
3005 [HQ 952343 and HQ 952769, both of 10/22/92).

Items that exclusively lend support to body parts are not classifiable in heading
3005. Stockings for varicose veins, suspensory bandages, supporting belts, athletic
supporters, maternity belts, thoracic support bandages, abdominal support bandages,
and supports for wrists, knees and elbows are not items belonging to the class or kind
of items enumerated in heading 3005. Some of these products may be described as
compression articles and be rated (in millimeters of mercury) for compression. Some of
these products may even be called “bandages” (certain washable, reusable elastic
bandages), but they are not designed for use as dressings, bandages, etc. as defined.
They are not used to treat wounds. They do not act as compresses applied to wounds.
They do not immobilize body parts in order to help in wound healing. They are strictly
utilized to help support muscles and joints during the course of normal or athletic
activity. The elasticity of such products makes them ideal for supporting sprains
because they allow limited motion and stretching in case of swelling so that circulation is
not impaired. If their intended supportive effect derives solely from their elasticity, they
are classifiable in subheadings of Section XI HTS (“Textiles and Textile Articles”)
according to composition and design [Chapter 90, Note 1(b)].

Orthopaedic articles are also not classifiable in heading 3005. This would include
any appliances used to correct or compensate for bodily deformities such as trusses,
and splints and fracture appliances used to immobilize injured body parts or assist in
setting fractures. Such articles would include plaster bandage splints used in
conjunction with a fracture bandage to add rigidity to a cast. Such articles are generally
classifiable in heading 9021. However, fracture bandages themselves are not
appliances. They are often presented in rolls and made of bandage materials such as
gauze impregnated with plaster of Paris, or of polyester cotton or fiberglass. They are
used as casting materials in forming casts. They are applied wet or softened to the
fractured limb and allowed to dry to form casts of varying degrees of hardness, rigidity,
water-resistance, and durability. Hard splints may be applied during the application of
such bandages for added strength and support. These types of casting bandages are
classifiable in heading 3005, but splints are not.

Triangular bandages used in first-aid work as head wound dressings, temporary slings
for immobilization, and temporary splints for broken bones, are classifiable in heading
3005, as long as they serve such general medical purposes and are packed for such
use [NY 832671 of 12/6/88 and NY 838151 of 3/23/89]. Such bandages are usually
made of cotton cloth. They can be cut to various sizes. To remain classifiable in the
heading, they should have the characteristics of a bandage and not of a specially
designed article to be used, e.g., exclusively as a splint or immobilizing limb holder.

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They should be of a weight suitable for a bandage, light enough to allow for easy
wrapping around the head or other injured body part. Heavy, less pliable materials
would indicate use only as a sling. The addition of grommets, strings, reinforced parts,
rigid pieces of plastic or fabric, etc. would also indicate a special application more in the
nature of a fracture appliance than a bandage [NY E82352 of 5/21/99]. A triangular
bandage imported together with a rigid splint would also indicate a more specialized
product than a general bandage.

Cotton swabs, whether of general or specialized use, have been consistently
determined to be classifiable outside of heading 3005 [HQ 953256 of 6/9/93 and NY
881943 of 1/26/93]. They are not similar to the exemplars of heading 3005. Swabs are
generally of unwoven material not suitable for wound dressing or treatment. In a
medical setting, they are used for no more than possible cleansing of or application of
an antiseptic to unbroken skin, and not for dressing wounds. When importing
merchandise of this nature, the importer should be prepared to submit samples,
instructional, technical and advertising literature, and compositional breakdowns by
weight.

POSSIBLE MISCLASSIFICATION CONSEQUENCES

Misunderstanding or misapplication of the principles of classification for heading 3005
may have duty and quota implications. The legal notes and Explanatory Notes to other
chapters and sections of the HTS contain numerous cross-references to the products of
heading 3005. For example, HTS Section XI (covering textiles and textile articles) Note
1(e) states that the Section does not cover articles of heading 3005 such as wadding,
gauze, bandages and similar articles for medical, surgical, dental or veterinary
purposes. Throughout the EN to the headings of Section XI there are exclusionary
statements referring to heading 3005. Similarly, there are exclusions in certain
headings of Sections X and XIII.

When a product is deemed not classifiable in heading 3005, it will become classifiable
elsewhere in the tariff depending upon its composition and construction. Products
made of textiles may end up being classified as carded or combed wool (headings 5111
and 5112), various cotton textile products, including woven products (Chapter 52),
vegetable textile products (Chapter 53), woven fabrics of man-made fibers (headings
5407 and 5408), fabrics of man-made staple fibers (headings 5512-5516), wadding or
nonwoven fabric (headings 5601 and 5603), gauze or narrow woven fabrics (headings
5803 and 5806), rubberized textile fabrics or other (non-pharmaceutically) impregnated
textile fabrics (headings 5906 and 5907), or certain knitted fabrics (heading 6002). This
list is not all-inclusive. Many Section XI products are dutiable, as opposed to the
products of heading 3005, and may also fall into textile categories subject to the quota
and visa requirements for such products.

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Section X covers paper and paper products. Certain products otherwise classifiable in
heading 3005 may be classified in Section X if they are found not to comply with the
requirements of heading 3005. Some may be classified in heading 4803 as cellulose
wadding, in heading 4811 as paper or cellulose wadding coated or impregnated with,
e.g., plastic, or in heading 4818 as certain household or hospital articles. Section XIII,
heading 6809, covers articles of plaster. Plaster-coated fracture bandages put up for
retail sale are classifiable in heading 3005 (see the previous section); those not put up
for retail sale are potentially classifiable in heading 6809. Most products of these
headings are dutiable.

THE IMPORTER’S RESPONSIBILITIES

Since the enactment of the Customs Modernization Act in December, 1993, the legal
burden of correctly classifying merchandise has shifted from Customs and Border
Protection to the importer, who must use reasonable care in carrying out this
responsibility. Prior to importation, the importer of record is responsible for determining
the nature, material composition, packing, and intended use of the merchandise in its
condition as imported.

The importer of bandages, dressings and similar products of heading 3005 should be
aware of the limiting language requirements of the heading. The prospective importer
should be familiar with the definitions and other classification issues and principles
contained in this publication. If an article does not belong to the class or kind of
merchandise used for wound treatment, or is not packed as required, classification
outside of heading 3005 is probable. Should a product be made of textile materials, the
importer should be aware of the possibility that the product may be subject to quota
restrictions and should be prepared to furnish a proper visa if required.

Prior to the importation of a particular bandage or bandage-like article, an importer or a
foreign supplier who wishes to verify the classification of the product may request a
binding ruling from Customs and Border Protection. See Part 177 of the CBP
Regulations (19 CFR 177). When requesting such a ruling, the inquirer should submit a
sample, marketing literature, use instructions, a description of any post-importation
manipulations, including possible repackaging, and composition by weight and value of
the component materials.

INVOICE REQUIREMENTS

In accordance with Section 141.86 of CBP Regulations (19 CFR 141.86), certain
general invoice information is required at the time of entry or entry summary. While
Title VI, Subpart B, Section 636 of the Customs Modernization Act (Mod Act) has
permitted some latitude in the application of Section 141.86, invoice information and
descriptions must be sufficient for the CBP Officer to determine admissibility and verify
classification and value of the imported merchandise. If invoice information is

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insufficient to resolve questions of admissibility or public health and safety, merchandise
may be detained and entries may be rejected. If an invoiced merchandise description is
found to be insufficient for classification or appraisement verification, the Port Director
retains the option of requesting additional information by issuance of a CBP Form 28, a
telephone call, or an importer interview. The importer of record is accountable for the
veracity of the information supplied in any invoice or supplemental documentation.

In the case of merchandise potentially classifiable in heading 3005, it would be helpful
to include in the merchandise description the exact trade name (if applicable), whether
or not it is an adhesive product, unit packing information (including sizes, thread counts,
measurements, etc.), and composition (including any materials with which the
merchandise may be impregnated). If such information is not included, the Port Director
may request it (along with samples if needed). In the case of merchandise made of
textile materials, additional information for certain classes of textile merchandise (such
as cotton or man-made fabrics) should be included as required by various sections of
19 CFR 141.89.

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ADDITIONAL INFORMATION

The Internet

The home page of U.S. Customs and Border Protection on the Internet’s World Wide
Web, provides the trade community with current, relevant information regarding CBP
operations and items of special interest. The site posts information -- which includes
proposed regulations, news releases, publications and notices, etc. -- that can be
searched, read on-line, printed or downloaded to your personal computer. The web site
was established as a trade-friendly mechanism to assist the importing and exporting
community. The web site also links to the home pages of many other agencies whose
importing or exporting regulations that U.S. Customs and Border Protection helps to
enforce. The web site also contains a wealth of information of interest to a broader
public than the trade community. For instance, on June 20, 2001, CBP launched the
“Know Before You Go” publication and traveler awareness campaign designed to help
educate international travelers.

The web address of U.S. Customs and Border Protection is
http://www.cbp.gov

Customs Regulations

The current edition of Regulations of the United States Bureau of Customs and Border
Protection is a loose-leaf, subscription publication available from the Superintendent of
Documents, U.S. Government Printing Office, Washington, DC 20402; telephone (202)
512-1800. A bound, 2003 edition of Title 19, Code of Federal Regulations, which
incorporates all changes to the Regulations as of April 1, 2003, is also available for sale
from the same address. All proposed and final regulations are published in the Federal
Register, which is published daily by the Office of the Federal Register, National
Archives and Records Administration, and distributed by the Superintendent of
Documents. Information about on-line access to the Federal Register may be obtained
by calling (202) 512-1530 between 7 a.m. and 5 p.m. Eastern time. These notices are
also published in the weekly CBP Bulletin described below.

CBP Bulletin

The CBP Bulletin and Decisions (“CBP Bulletin”) is a weekly publication that contains
decisions, rulings, regulatory proposals, notices and other information of interest to the
trade community. It also contains decisions issued by the U.S. Court of International
Trade, as well as customs-related decisions of the U.S. Court of Appeals for the Federal
Circuit. Each year, the Government Printing Office publishes bound volumes of the
CBP Bulletin. Subscriptions may be purchased from the Superintendent of Documents
at the address and phone number listed above.

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Importing Into the United States

This publication provides an overview of the importing process and contains general
information about import requirements. The February 2002 edition of Importing Into the
United States contains much new and revised material brought about pursuant to the
Customs Modernization Act (“Mod Act”). The Mod Act has fundamentally altered the
relationship between importers and U.S. Customs and Border Protection by shifting to
the importer the legal responsibility for declaring the value, classification, and rate of
duty applicable to entered merchandise.

The February 2002 edition contains a section entitled "Informed Compliance." A key
component of informed compliance is the shared responsibility between U.S. Customs
and Border Protection and the import community, wherein CBP communicates its
requirements to the importer, and the importer, in turn, uses reasonable care to assure
that CBP is provided accurate and timely data pertaining to his or her importation.

Single copies may be obtained from local offices of U.S. Customs and Border
Protection, or from the Office of Public Affairs, U.S. Customs and Border Protection,
1300 Pennsylvania Avenue NW, Washington, DC 20229. An on-line version is
available at the CBP web site. Importing Into the United States is also available for
sale, in single copies or bulk orders, from the Superintendent of Documents by calling
(202) 512-1800, or by mail from the Superintendent of Documents, Government Printing
Office, P.O. Box 371954, Pittsburgh, PA 15250-7054.

Informed Compliance Publications

U.S. Customs and Border Protection has prepared a number of Informed Compliance
publications in the “What Every Member of the Trade Community Should Know
About:...” series. Check the Internet web site http://www.cbp.gov for current
publications.

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Value Publications

Customs Valuation under the Trade Agreements Act of 1979 is a 96-page book
containing a detailed narrative description of the customs valuation system, the customs
valuation title of the Trade Agreements Act (§402 of the Tariff Act of 1930, as amended
by the Trade Agreements Act of 1979 (19 U.S.C. §1401a)), the Statement of
Administrative Action which was sent to the U.S. Congress in conjunction with the TAA,
regulations (19 C.F.R. §§152.000-152.108) implementing the valuation system (a few
sections of the regulations have been amended subsequent to the publication of the
book) and questions and answers concerning the valuation system. A copy may be
obtained from U.S. Customs and Border Protection, Office of Regulations and Rulings,
Value Branch, 1300 Pennsylvania Avenue,
(Mint Annex) NW, Washington, D.C. 20229.

Customs Valuation Encyclopedia (with updates) is comprised of relevant statutory
provisions, CBP Regulations implementing the statute, portions of the Customs
Valuation Code, judicial precedent, and administrative rulings involving application of
valuation law. A copy may be purchased for a nominal charge from the Superintendent
of Documents, Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-
7054. This publication is also available on the Internet web site of U.S. Customs and
Border Protection.

The information provided in this publication is for general information
purposes only. Recognizing that many complicated factors may be
involved in customs issues, an importer may wish to obtain a ruling under
CBP Regulations, 19 C.F.R. Part 177, or obtain advice from an expert
(such as a licensed Customs Broker, attorney or consultant) who
specializes in customs matters. Reliance solely on the general
information in this pamphlet may not be considered reasonable care.

Additional information may also be obtained from U.S. Customs and Border Protection
ports of entry. Please consult your telephone directory for an office near you. The
listing will be found under U.S. Government, Department of Homeland Security.

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“Your Comments are Important”

The Small Business and Regulatory Enforcement Ombudsman and 10 regional
Fairness Boards were established to receive comments from small businesses about
Federal agency enforcement activities and rate each agency’s responsiveness to small
business. If you wish to comment on the enforcement actions of U.S. Customs and
Border Protection, call 1-888-REG-FAIR (1-888-734-3247).

REPORT SMUGGLING 1-800-BE-ALERT OR 1-800-NO-DROGA

Visit our Internet web site: http://www.cbp.gov

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