CLA-2 OT:RR:CTF:TCM H196055 LWF
Mr. Jay Mittleman
KCI USA, Inc.
P.O. Box 659508
San Antonio, TX 78265-9508
RE: Revocation of New York Ruling Letter (NY) N175698, dated August 15, 2011; tariff classification of self-adhesive surgical drapes from Mexico
Dear Mr. Mittleman:
This letter is to inform you that U.S. Customs and Border Protection (CBP) has reconsidered New York Ruling Letter (NY) N175698, dated August 15, 2011, concerning the tariff classification of KCI USA, Inc.’s (KCI) Vacuum Assisted Closure® (“V.A.C.®”) self-adhesive surgical drapes, imported from Mexico and used for covering wound dressings (“the surgical drapes”). In NY N175698, CBP classified the surgical drapes in heading 3919, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Self-adhesive plates, sheets, film, foil, tape, strip and other flat shapes, of plastics, whether or not exceeding 20 cm.” Upon your request, dated December 1, 2011, we have reviewed NY N175698 and find the ruling to be in error. Accordingly, for the reasons set forth below, CBP is revoking ruling letter NY N175698.
Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. § 1625(c)(1)), as amended by section 623 of Title VI, notice proposing to revoke ruling letter NY N175698 was published on May 6, 2015 in the Customs Bulletin and Decisions, Vol. 49, No. 5. CBP received zero comments in response to the proposed revocation.
FACTS:
The merchandise at issue consists of packages of Vacuum Assisted Closure® self-adhesive surgical drapes imported and sold in packages containing either five (Item KCI-60566; M6275097/5) or ten (Item KCI-60515; M6275009/10) surgical drapes. CBP previously described the individual V.A.C.® surgical drapes in NY N175698, as follows:
The product is identified as a self-adhesive therapy drape. The drape is used with Vacuum Assisted Closure (V.A.C.) therapy apparatus to facilitate the protection and treatment of wounds. V.A.C. therapy is typically used by medical professionals in the management of severe wounds or incisions and uses an electric suction pump with a storage container to assist in the removal of wound fluids and in keeping the wound from opening. A V.A.C. therapy system dressing kit generally consists of a foam plastic dressing to be placed directly over the wound, a self-adhesive plastic sheet called a therapy drape for holding the foam dressing in place, and tubing and connectors to secure to the suction pump.
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The V.A.C.® self-adhesive surgical drapes are exclusively intended for direct sale without re-packing to medical professionals for use in wound care and treatment. The V.A.C.® self-adhesive surgical drapes serve as an integral component of the V.A.C.® wound therapy system and perform independent functions by protecting the wound, preventing contaminants from entering the wound area, and maintaining optimal moisture levels to support the healing environment. The V.A.C.® self-adhesive surgical drapes are not impregnated or coated with pharmaceutical substances.
ISSUE:
Whether KCI’s V.A.C.® self-adhesive surgical drapes are classified in heading 3005, HTSUS, as wadding, gauze, bandages and similar articles, put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes; or heading 3919, HTSUS, as self-adhesive sheets of plastics, whether or not exceeding 20 cm.
LAW AND ANALYSIS:
Merchandise imported into the United States is classified under the HTSUS. Tariff classification is governed by the principals set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context with requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law for all purposes.
GRI 1 requires that classification be determine first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in their appropriate order.
The following HTSUS provisions will be referenced:
3005 Wadding, 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
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3919 Self-adhesive plates, sheets, film, foil, tape, strip and other flat shapes, of plastics, whether or not exceeding 20 cm
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Note 2 to Section VI, HTSUS, states:
2. Subject to note 1 above, goods classifiable in heading 3004, 3005, 3006, 3212, 3303, 3304, 3305, 3306, 3307, 3506, 3707 or 3808 by reason of being put up in measured doses or for retail sale are to be classified in those headings and in no other heading of the tariff schedule.
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The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While not legally binding, the ENs provide a commentary on the scope of each heading of the HS and are thus useful in ascertaining the proper classification of merchandise. It is CBP’s practice to follow, whenever possible, the terms of the ENs when interpreting the HTSUS. See T.D. 89-90, 54 Fed. Reg. 35127, 35128 (August 23, 1989).
EN 30.05, HTS, states, in pertinent part, as follows:
This heading covers articles such as wadding, gauze, bandages and the like, of textile, paper, plastic, etc., impregnated or coated with pharmaceutical substances (counter-irritant, antiseptic, etc.) for medical, surgical, dental or veterinary purposes.
These articles include wadding impregnated with iodine or methyl salicylate, etc., various prepared dressings, prepared poultices (e.g., linseed or mustard poultices), medicated adhesive plasters, etc. They may be in the piece, in discs or in any other form.
Wadding and gauze for dressings (usually of absorbent cotton) and bandages, etc., not impregnated or coated with pharmaceutical substances, are also classified in this heading, provided they are exclusively intended (e.g., because of the labels affixed or special folding) for sale directly without re-packing, to users (private persons, hospitals, etc.) for use for medical, surgical, dental or veterinary purposes.
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In light of the requirements set forth, supra, by Note 2 to Section VI, HTSUS, the classification of the V.A.C.® self-adhesive surgical drapes turns on whether the merchandise is described by the terms of heading 3005, HTSUS. Heading 3005, HTSUS, provides for “Wadding, 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.”
The term “bandages” is not defined in the HTSUS or the ENs. However, when a tariff term is not defined by the HTSUS or the legislative history, its correct meaning is its common, or commercial, meaning. Rocknel Fastener, Inc. v. United States, 267 F.3d 1354, 1356 (Fed. Cir. 2001) (“To ascertain the common meaning of a term, a court may consult ‘dictionaries, scientific authorities, and other reliable information sources’ and ‘lexicographic and other materials.” (quoting C.J. Tower & Sons of Buffalo, Inc. v. United States, 673 F.2d 1268, 1271 (Fed. Cir. 1982))).
The Oxford English Dictionary defines the term “bandage,” in relevant part, as “A strip or band of woven material used to bind up a wound, sore, or fractured limb.” Oxford English Dictionary, http://www.oed.com (last visited February 4, 2013). Consistent with the common meaning of the term “bandage,” CBP has previously interpreted the term “bandage” to include pieces of material applied to a body part to make a compression, absorb drainage, prevent motion, retain surgical dressing, or lend support to a wound. See NY I84715, dated August 8, 2002; HQ 966637, dated October 22, 2003; and HQ H22137, dated October 11, 2012. Additionally, this office notes that in CBP’s Informed Compliance Publication (ICP), What Every Member of the Trade Community Should Know About: Wadding, Gauze, Bandages, and Similar Articles (Heading 3005, HTSUS), dated July 2006 (“ICP: Heading 30.05”), CBP has described the term “dressing,” used as an exemplar in the text of heading 3005, HTSUS, to be a general term that includes, among other articles, “bandages” and “protectives” for wounds or injuries.
By contrast, CBP has previously held that certain articles not used for the treatment and care of wounds or injuries fall outside the scope of heading 3005, HTSUS. For example, in HQ 962172, dated May 5, 1999, CBP declined to classify a magnetic bandage in heading 3005, HTSUS, through application of ejusdem generis, because it could not be placed on an open wound and it therefore lacked common characteristics of the articles of heading 3005. Similarly, in HQ 966555, dated September 9, 2003, CBP determined that a hydrocolloidal polyethylene film wafer with plastic flange—adhered to the abdomen to secure ostomy pouches for the collection of bodily waste following surgical removal of parts of the intestine or urinary tract—was not classifiable in heading 3005, HTSUS, because:
[The] skin covered by the wafer is intact and there is no wound to cover… Hence, the function of the wafer is clearly to protect intact skin rather than to dress a wound[.]
Moreover, CBP stated in ruling letter HQ 966555 that although the hydrocolloidal polyethylene film wafer was designed to protect the skin surrounding a stoma from irritation and was similar in composition material to other hydrocolloidal dressings, it was not similar in function to wadding, gauze bandages, and similar articles of heading 3005, HTSUS, because:
[I]t is not applied to a wound with the intent to protect the wound from debris, absorb exudate from the wound, or provide the environment for healing. HQ 966555, at 6.
As such, this office observes that the common meaning of the term “bandages” of heading 3005, HTSUS—describing materials applied for the treatment and care of wounds or injuries—is reflected in several previous CBP ruling letters, supra. Consequently, a finding that the instant V.A.C.® self-adhesive surgical drapes are used for wound care and treatment would support classification of the merchandise as “bandages” of heading 3005, HTUS.
In addition to meeting the common meaning of the term “bandage,” however, the text of heading 3005, HTSUS, also requires that articles of the heading meet one of two additional descriptions—namely, of being “impregnated or coated with pharmaceutical substances” or “put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes.” Moreover, the ENs to heading 30.05, HS, state that wadding and gauze for dressings (usually of absorbent cotton) and bandages, etc., not impregnated or coated with pharmaceutical substances, are also classified in this heading, provided they are exclusively intended (e.g., because of the labels affixed or special folding) for sale directly without re-packing to users (private persons, hospitals, etc.) for use for medical, dental, or veterinary purposes. Here, inasmuch as the V.A.C.® self-adhesive surgical drapes are not impregnated or coated with pharmaceutical substances, this office need only consider whether the samples are put up for retail sale for medical, surgical, dental or veterinary purposes.
Upon review of physical characteristics and intended uses of the V.A.C.® self-adhesive surgical drapes, this office finds that the surgical drapes are designed as an integral component of the V.A.C.® wound therapy system and serve additional independent functions by protecting the wound, preventing contaminant from entering the wound area, and maintaining optimal moisture levels to support the healing environment. Additionally, we note that KCI’s “Basic V.A.C.® Dressing Application Pocket Guide”—which contains pictures showing the basic steps to apply a V.A.C.® self-adhesive surgical drape—clearly indicates that the merchandise is put up for retail sale for medical purposes. Consequently, this office finds that although the V.A.C.® self-adhesive surgical drapes are not impregnated or coated with pharmaceutical substances, the merchandise is put up for direct sale without re-packing to medical professionals for use in wound care and treatment.
In finding that the V.A.C.® self-adhesive surgical drapes are described by the common meaning of the term “bandages,” as provided for in heading 3005, HTSUS, the merchandise is classifiable under subheading 3005.10.50, HTSUS, as “Wadding, 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: Adhesive dressings and other articles having an adhesive layer: Other.” In accord with Note 2 to Section VI, HTSUS, this office need not examine classification of the merchandise in Chapter 39, HTSUS, or other headings of the tariff schedule.
In classifying the V.A.C.® self-adhesive surgical drapes in heading 3005, HTSUS, this office notes that in ruling letter HQ 967207, dated January 11, 2005, CBP similarly classified—as part of its GRI 3 analysis concerning the “Safe Start IV Start Pak”—a “Tegaderm® transparent dressing” in heading 3005, HTSUS. There, CBP described the Tegaderm® dressing as being used to cover, secure, and protect an IV catheter and insertion site after an IV is inserted into a patient’s vein. Insomuch as Tegaderm® dressing and the instant V.A.C.® self-adhesive surgical drapes are used on the human body to cover and protect open wounds during medical treatment, this office observes that the function of the instant V.A.C.® self-adhesive surgical drapes is substantially similar to that of the Tegaderm® dressing. Consequently, the classification of the Tegaderm® dressing under heading 3005, HTSUS, in ruling letter HQ 967207 is consistent with the classification of the V.A.C.® self-adhesive surgical drapes under the same provision.
HOLDING:
By application of GRI 1 and Section VI, Section Note 2, the V.A.C.® self-adhesive surgical drapes are classified under heading 3005, HTSUS, specifically in subheading 3005.10.50, which provides for “Wadding, 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: Adhesive dressings and other articles having an adhesive layer: Other.” The 2014 column one, general rate of duty is free.
Duty rates are provided for convenience only and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at http://www.usitc.gov.
In accordance with 19 U.S.C. § 1625(c), this ruling will become effective 60 days after publication in the Customs Bulletin and Decisions.
EFFECT ON OTHER RULINGS:
In accordance with the above analysis, NY N175698, dated August 15, 2001, is hereby REVOKED.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division