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HQ 963746

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May 16, 2001

CLA-2 RR:CR:GC 963746 AM

CATEGORY: CLASSIFICATION

TARIFF NO.: 4015.19.10

Port Director
U.S. Customs Service
C/o Chief, Residual Liquidation and Protest Branch 6 World Trade Center, Room 761
New York, NY 10048-0945

RE: Protest 1001-99-100923; latex gloves

Dear Port Director:

This is in reference to protest 1001-99-100923 concerning the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of latex rubber gloves. The merchandise was entered on March 17, 1998, and the entry was liquidated on January 29, 1999, under subheading 4015.19.00, HTSUS, as other latex gloves. A protest was timely filed on February 24, 1999.

In reviewing this protest, we reconsidered Customs Headquarters rulings (HQs) 951033, dated June 8, 1992; 951586, dated June 23, 1992; 957522 and 957561, both dated May 24, 1995; and 961270, dated April 15, 1998, all of which concerned the classification of rubber gloves. After careful consideration, in accordance with 19 U.S.C. 1625(c), in HQ 964836, 964837, 964838, and 964839, dated May 2, 2001, (published in the May 16, 2001 Customs Bulletin, Vol. 35, No. 20), we revoked HQs 951033, 951586, 957522, and, 957561 and 961270.

FACTS:

The subject merchandise is pre-powdered and powder free seamless, disposable latex rubber gloves (gloves) from Malaysia in one hundred (100) count dispenser boxes. The boxes are labeled "for industrial use." The importer states that these latex gloves are marketed and sold only for industrial use and in the food service industry.

ISSUE:

How are pre-powdered and powder free seamless, disposable latex rubber gloves imported in one hundred count dispenser boxes for sale to industrial and food service industries classified?

LAW AND ANALYSIS:

Merchandise imported into the U.S. is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context that 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.

GRI 1 requires that classification be determined 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 order. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and mutatis mutandis, to the GRIs. In interpreting the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are (official interpretation of the Harmonized System at the international level) generally indicative of the proper interpretation of the HTSUS. See T.D. 8980, 54 Fed. Reg. 35127 (August 23, 1989).

Additional U.S. Rule of Interpretation 1(a) requires that "a tariff classification controlled by use (other than actual use) is to be determined in accordance with the use in the United States at, or immediately prior to, the date of importation, of goods of that class or kind to which the imported goods belong, and the controlling use is the principal use".

The following HTSUS provisions are under consideration:

4015 Articles of apparel and clothing accessories (including gloves), for all purposes, of vulcanized rubber other than hard rubber: Gloves:

4015.11.00 Surgical and medical

4015.19 Other:

4015.19.10 Seamless

The EN for subheading 4015.11, states as follows: "[S]urgical gloves are thin, highly tear-resistant articles manufactured by immersion, of a kind worn by surgeons. They are generally presented in sterile packs."

Subheading 4015.11, HTSUS, is a principal use provision. The court in E. M. Chemicals v. United States, 20 C.I.T. 382, 923 F. Supp. 202 (1996 Ct. Intl. Trade) explained the application of these types of HTSUS provisions thus:

When applying a "principal use" provision, the Court must ascertain the class or kind of goods which are involved and decide whether the subject merchandise is a member of that class. See supra Additional US Rule of Interpretation 1 to the HTSUS. In determining the class or kind of goods, the Court examines factors which may include: (1) the general physical characteristics of the merchandise; (2) the expectation of the ultimate purchasers; (3) the channels of trade in which the merchandise moves; (4) the environment of the sale (e.g., the manner in which the merchandise is advertised and displayed); (5) the usage of the merchandise; (6) the economic practicality of so using the import; and (7) the recognition in the trade of this use. United States v. Carborundum Co., 63 C.C.P.A. 98, 102, 536 F.2d 373, 377, cert. denied, 429 U.S. 979, 50 L. Ed. 2d 587, 97 S. Ct. 490 (1976); see also Lenox Coll., 20 C.I.T., Slip Op. 96-30, at page 5.

Our decisions in HQs 951033, 951586, 957522, 957561, and 961270, classifying disposable latex gloves for industrial use in subheading 4015.11.00, HTSUS, the provision for surgical and medical latex gloves, were based on the premise that industrial use gloves and medical use gloves are actually the same product and hence belong to the same class or kind of merchandise. In those rulings, we noted that both industrial use and medical use gloves were made on the same machines and of the same materials. We went on to state that: "there does not appear to be any basis for distinguishing between these gloves and medical use latex gloves." We now believe this statement is in error.

At the outset, we note that, if non-medical use gloves and medical use gloves belong to the same class or kind of merchandise, then it is no more incumbent upon Customs to classify all latex gloves as "surgical and medical" gloves than it would be to classify all the gloves as "other latex gloves." In fact, latex gloves which bear the medical use label are sold by the same retailers and used in the same way as general purpose non-medical use gloves, thus, the applicable class or kind of goods to which all latex gloves would belong if we considered them as one is "other latex gloves" rather than "surgical and medical" gloves.

In fact, the international language of the tariff does not refer to medical gloves at all. Through historical happenstance, the term "Surgical and medical" was carried over from the Tariff Schedule of the United States ("TSUS"), the precursor to the HTSUS, to subheading 4015.11, HTSUS. The U.S. International Trade Commission is considering bringing the HTSUS in conformity with the international language. Nevertheless, we must interpret the language of the HTSUS as presently worded.

Although the text of the EN seems to relate only to "surgical gloves," given the history noted above, it is at least ambiguous whether EN 4015.11 applies to only surgical gloves, or whether, in the HTSUS, where the subheading is entitled "surgical and medical", Congress intended for the EN to apply to both terms. Regardless, there is a general concern, elicited by the EN, that the gloves classified in subheading 4015.11 be of a quality different from those classified as "other" latex gloves. In the United States, that quality difference is governed by Food and Drug Administration ("FDA") regulations, which, in turn, governs the use of the gloves. Such gloves undergo stringent testing of their leak resistance and adulteration. (21 CFR 800.20). According to a source at the FDA, industrial use gloves are latex gloves that have failed this test or were not tested. Manufacturers may then sell the untested, adulterated or leaky gloves to the cosmetic, food handling, electronic and other industries. There are strict penalties for attempting to insert industrial use gloves into the medical use market because they are of differing quality. (21 CFR 800.55). The quality difference and marketing of these gloves, where the tear resistance of the article is specifically noted in the EN, distinguishes the surgical and medical use gloves from the non-medical use gloves.

Correct application of the Carborundum factors, the legal standard for analysis of principal use provisions, reveals distinctions between medical and non-medical use latex gloves based on real differences in the use of the gloves, whether or not any particular glove, from a box labeled "not for medical use" could theoretically form an effective barrier against blood-borne pathogens and other bodily fluids.

The general physical characteristics of a lot of non-medical use gloves may include a higher percentage of leaks, tears or pinholes than found in medical use gloves. While any particular non-medical use glove is likely to be physically exactly the same as a medical use glove, the imported product is non-medical use gloves packaged for retail sale. A given box of non-medical use gloves likely contains a higher number of defective gloves than a given box of medical use gloves.

The expectation of the ultimate purchaser of medical gloves is that the glove serves as an effective barrier between blood-borne pathogens that may be lethal, and the wearers skin. The expectation of the purchaser of non-medical use gloves is that the gloves will protect the wearer against chemicals and other irritants and will create a generally hygienic environment for handling food, cosmetics and other products. Expectations about the quality of the glove are much higher among the ultimate purchasers of medical use gloves. So much so, that the FDA has proposed a new rule requiring additional testing of the tear resistance and degradation potential of medical use gloves due to consumer concerns about the quality of medical use gloves (64 FR 41710, July 30, 1999). In fact, testing a particular lot of gloves for labeling as medical use gloves increases the marketing potential of the gloves because the ultimate purchaser prefers the assurance of a high quality product.

Medical use gloves follow channels of trade to clinical settings. Although non-medical use gloves are sold through the same retailers as some medical use gloves, non-medical use gloves do not enter the same industries as medical use gloves. Medical use gloves appear in clinical settings where non-medical use gloves are prohibited from use under FDA guidelines (21 CFR 801 et seq.). Although another agency's regulations are not controlling in Customs classification decisions, where Customs must apply a "use" provision to merchandise, the controlling regulatory scheme is indeed relevant.

The environment of the sale includes a label stating that non-medical use gloves are only for industrial use or for non-medical use. Medical use gloves have greater consumer appeal because of their assurance of quality and are marketed accordingly.

The actual usage of gloves labeled specifically for non-medical use can not be a medical use because such use is prohibited by the FDA (21 CFR 801 et seq.).

There is a slight cost difference in medical and non-medical use gloves but, this may not interfere with the use of medical gloves as non-medical use gloves. However, the proposed new rule by the FDA, which would require additional testing of medical use gloves, may again make using medical use latex gloves as industrial or general purpose latex gloves prohibitive due to the difference in cost of the gloves. Nevertheless, the cost difference is not the only factor to consider.

The recognition in the trade of industrial use is apparent by the labeling "not for medical use."

On balance, application of the Carborundum factors reveals that the correct classification for gloves imported for and labeled for non-medical use is in subheading 4015.19.10, the provision for "[A]rticles of apparel and clothing accessories (including gloves), for all purposes, of vulcanized rubber other than hard rubber: [G]loves: [O]ther: [S]eamless".

HOLDING:

Latex gloves labeled for non-medical use are classified in subheading 4015.19.10, HTSUS, the provision for "[A]rticles of apparel and clothing accessories (including gloves), for all purposes, of vulcanized rubber other than hard rubber: [G]loves: [O]ther: [S]eamless." The protest is DENIED.

In accordance with Section 3A(11)(b) of Customs Directive 099 3550065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.

Sixty days from the date of the decision, the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.gov, by means of the Freedom of Information Act, and other methods of public distribution.

Sincerely,

John Durant, Director

Previous Ruling Next Ruling

See also:

• Tariff No.: 4015.11.00 - Surgical and medical gloves of vulcanized rubber other than hard rubber
• Tariff No.: 4015.19.10 - Seamless gloves of vulcanized rubber other than hard rubber, other than surgical or medical gloves