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HQ 965530




July 15, 2002

CLA-2 RR:CR:GC 965530AM

CATEGORY: CLASSIFICATION

TARIFF NO.: 4015.19.10

Mr. Donald S. Stein
Manatt, Phelps & Phillips, LLP
1501 M Street N.W., Suite 700
Washington, D.C. 20005

RE: Reconsideration of NY H86590; nitrile gloves

Dear Mr. Stein:

This is our decision regarding your letter, dated March 8, 2002, on behalf of your client, Kimberly-Clark Corporation, requesting reconsideration of New York Ruling Letter (NY) H86590, dated January 22, 2002, regarding the tariff classification, pursuant to the Harmonized Tariff Schedule of the United States (HTSUS), of nitrile gloves packages marked “for industrial use only.” In preparing this ruling, we also considered arguments you made in a telephone conference with a member of my staff on July 12, 2002.

FACTS:

The articles under consideration are disposable, unsterilized, 12 inch long ambidextrous nitrile gloves imported in bulk from Thailand packed in 100 count plastic bags labeled “for the cleanroom environment” and “for industrial use only.” The merchandise exceeds all ASTM standards for nitrile exam gloves and provide additional protection via the longer length of the glove.

NY H86590 held that nitrile 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, mittens and mitts: [O]ther: [O]ther: [S]eamless."

ISSUE:

Whether disposable, unsterilized, 12 inch long ambidextrous nitrile gloves marked for industrial use are classifiable under subheading 4015.11.01, HTSUS, the provision for surgical gloves of vulcanized rubber, 4015.19.05, the provision for medical gloves of vulcanized rubber, or 4015.19.10, the provision for other seamless gloves of vulcanized rubber.

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 subheadings are relevant to the classification of this product:

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

4015.11.01 Surgical

4015.19 Other:

4015.19.05 Medical

Other:

4015.19.10 Seamless

You argue that Headquarters Ruling (HQ) 964836, dated May 2, 2001, “does not affect the gloves imported by Kimberly-Clark . . . because the Kimberly-Clark’s gloves are unlike the industrial use gloves covered by the ruling.” We disagree. Although the structure of heading 4015 has changed in the 2002 HTSUS, including a new tariff number for medical gloves, the analysis in HQ 964836 remains the same. In that ruling which analyzed the classification of latex gloves labeled “not for medical use,” we stated that “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".

Analyzing the factors listed in 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) for the instant merchandise reveals the following:

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. You state that the instant merchandise is specifically manufactured for the clean room environment and exceeds the ASTM standards for nitrile exam gloves. However, they are imported marked for industrial use. In general, gloves marked for industrial use may or may not meet the standards while medical gloves must meet the standards under the Food and Drug Administration ("FDA") regulations. (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 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. You state that the expectations among the specific purchasers of the instant clean room industrial use gloves is actually higher than that for medical use gloves. However, with the words "for industrial use only" marked on the box of gloves, the ultimate purchaser can not know that the instant gloves are of a greater quality than medical use gloves. Rather, the expectations about the quality of the glove marked for industrial use are generally lower than those of the ultimate purchasers of medical use gloves.

Medical use gloves follow channels of trade to clinical settings. You state that the instant clean room gloves are sold to the same distributors as medical use gloves. However, the instant merchandise does not appear in the clinical settings in which medical use gloves are used.

The environment of the sale includes a label stating that the clean room gloves are only for industrial use.

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.).

You state that the cost to produce the instant merchandise is significantly higher than that to produce the medical use gloves. Whether higher or lower, the significant cost differential distinguishes them from the class or kind of good to which medical use gloves belong.

The recognition in the trade of industrial use is apparent by the labeling "for industrial use."

On balance, application of the Carborundum factors reveals that the the instant merchandise does not belong to the class or kind of goods principally used as surgical or medical gloves.

HOLDING:

Nitrile 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, mittens and mitts: [O]ther: [O]ther: [S]eamless." NY H86590 is AFFIRMED.

Sincerely,

Myles B. Harmon, Acting Director
Commercial Rulings Division


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