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HQ 951033

June 8, 1992

CLA-2 CO:R:C:F 951033 ALS


TARIFF NO.: 4015.11.0000

District Director of Customs
55 Erieview Plaza
Cleveland, Ohio 44114

RE: Request for Further Review of Protest 4103-91-000187, dated June 13, 1991, Concerning Disposable Latex Rubber Gloves

Dear Mr. Nelson:

This ruling is on a protest that was filed against your decision of May 17, 1991, in the liquidation of several entries covering the referenced items. Other protests covering the same or similar gloves were also filed. Consideration of this matter was delayed since one or more of the protest files were misdirected during processing.


The articles under consideration are two styles of disposable latex gloves. One style is ambidextrous, powdered for easy on- off, comes in 9-1/2 inch length and .005 inch thickness and comes in two sizes. It is packaged in boxes of 100 and in polybags of 1000. The sample box provided has a stick-on label bearing the legend "FOR INDUSTRIAL USE". Advertising literature provided by the protestant specifies a number of uses for the gloves and states that they are for use "[a]nywhere you need a light duty liquidproof glove." Information on the box specifies that the gloves are made from natural latex for greater finger dexterity extra sensitivity and tactility, they do not cause hand fatigue, they have snug rolled cuffs for greater protection and they keep hands cool and comfortable.

A second style of the latex gloves is made for both left hand and right hand application. They come in a 12 inch length, are .009 inches thick, have an anti-slip bisque finish and come in half-sizes ranging from 6 to 9. Some of the gloves and are packaged in an individual heat-sealed polybag and some are packaged 50 right-hand or left-hand gloves per heat-sealed polybag. Both of the aforementioned packages are subsequently packaged in master heat sealed polybags which, in turn, are packaged so that there are 200 pairs per case. These gloves are noted to provide a combination of comfort, sensitivity and fit, offer a secure grip for both wet and dry applications and to provide one of the industry's lowest particulate levels for use in a clean room environment.


What is the classification of 100 percent natural latex disposable rubber gloves?


Classification of merchandise under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) is governed by the General Rules of Interpretation (GRI's) taken in order. GRI 1 provides that the classification is determined first in accordance with the terms of the heading and any relative section and chapter notes. If GRI 1 fails to classify the goods and if the heading and legal notes do not otherwise require, the remaining GRI's are applied, taken in order.

The articles under consideration were classified by Customs as surgical and medical gloves under subheading 4015.11.0000, HTSUSA. The protestant states that the gloves are industrial gloves classifiable under subheading 4015.19.1010, HTSUSA. The protestant notes that these gloves are labelled for industrial use and that they are sold to distributors who sell to industrial companies for various applications. Advertising literature provided by the protestant states that the ambidextrous gloves are good "[a]nywhere you need a light-duty liquidproof glove" and specifies use in laboratory analysis/technical work, food processing and handling, quality control, electronic assembly, polishing, equipment clean-up, nuclear power plant clean-up, pharmaceutical plants, cosmetic manufacturing, semi-conductor plans, acid etching, camera lens and film processing, watch manufacturing, medical kit manufacturing, biotechnology, airline cabin maintenance, USDA veterinary departments, fast-food - 3 -
preparation and quality control inspection. Similar advertising literature regarding the gloves which are specifically designed for left or right hand application states that such gloves are for use in electronics, pharmaceuticals, aerospace and biotech controlled environments and in environments where there is a need for reduced particle contamination.

The protestant also states that the gloves are marked "FOR INDUSTRIAL USE" in order to comply with the Food and Drug Administration (FDA) requirements for disposable rubber latex gloves used with industrial applications.

In considering this matter we consulted the Explanatory Notes to the Harmonized System which represents the opinion of the international classification experts. We noted that the subheading explanatory note to subheading 4015.11 describes surgical gloves as "...thin, highly tear-resistant article manufactured by immersion, of a kind worn by surgeons. They are generally presented in sterile packs."

We also consulted the regulations of the FDA. In this regard, we were unable to confirm that there is a regulation of that agency which requires the labelling of gloves for industrial use. A FDA source informally advised us that that agency would not be interested in latex gloves being brought in for non-medical purposes. He was unable to confirm that such a regulation existed. We also consulted Part 800 of the FDA Regulations (21 CFR Part 800) regarding patient examination and surgeon's gloves; adulteration. These regulations, written in light of the prevalence of human immunodeficiency virus (HIV) infection and the risk of clinical transmission of other infections, define adulteration of the referenced gloves and establish the sample plans and test method to be used to determine if the gloves are adulterated. Those regulations, without further definition, include gloves which meet the adulteration and test method specifics therein which are identified as medical or surgical gloves.

Section 880.6250, FDA Regulations (21 CFR 880.6250) defines a patient examination glove as "...a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between and examiner." Section 878.4460, FDA Regulations (21 CFR 878.4460) defines a surgeon's glove as "...a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination." While there is no FDA - 4 -
regulatory requirement that these gloves be sterile, FDA guidelines do provide that gloves utilized during operating procedures meet certain sterility requirements. The aforementioned FDA source advised us that appropriate sterility requirements may be met at or subsequent to importation if the gloves are identified as medical or surgical gloves. The sterility requirements must be met before the gloves are made available to the end-user.

In discussions with both an FDA source and a practicing physician we confirmed that only a small category of these gloves, i.e. surgeon's gloves utilized when there is an open wound, such as during an operation, must be sterile. Examination gloves, even those utilized for rectal and vaginal examinations, are not normally sterile. These gloves are packaged in dispenser boxes in the same manner as the protestants ambidextrous gloves. We were unable to distinguish any difference between such gloves which are the subject of this protest and those which were observed in the physician's office.

The physician advised us that a sterile environment is only a concern when there is an open wound where blood may be present. He noted that non-sterile examination gloves which protect the physician from a disease and assure that a disease will not be transmitted from one patient to another via the physician are satisfactory for this purpose.

While the FDA Regulations are not binding on the Customs Service and are referenced for information purposes only, we noted that those regulations, while defining qualities to be possessed by the surgeon's and examination gloves, did not provide any characteristics which would be unique to those gloves. We also noted that the documentation provided by the protestant did not provide any basis for distinguishing between its product and medical gloves. Other than statements that the gloves would be used for industrial purposes and a label, stick-on in the case of the ambidextrous gloves, which stated they were for industrial use, there does not appear to be any basis for distinguishing these gloves from those described as medical gloves.


The subject disposable latex gloves are classifiable under subheading 4015.11.0000, HTSUSA, and are subject to a general rate of duty of 3.7 percent ad valorem. Such articles, if the
product of Thailand, which meet the requirements of General Note 3(c)(ii) of the HTSUSA, regarding the General System of Preferences (GSP), are eligible for a free special rate of duty upon compliance with the provisions of section 10.171 et seq., Customs Regulations (19 CFR 10.171 et seq.). Such articles, if the product of Malaysia, are presently excluded from such treatment by subdivision (c)(ii)(D) of General Note 3, HTSUSA.

Since the rate of duty under the classification indicated above is the same as the liquidated rate, you are instructed to deny the protest in full. A copy of this decision should be attached to Customs Form 19 and provided to the protestant as part of the notice of action on the protest.


John Durant, Director
Commercial Rulings Division

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