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HQ 957561




May 24, 1995

CLA-2 R:C:F 957561 ALS

CATEGORY: CLASSIFICATION

TARIFF NO.: 4015.11.0000

District Director of Customs
610 S. Canal Street
Chicago, IL 60607

RE: Request for Further Review of Protest 3901-94-102358, dated October 20, 1994, Concerning Disposable Natural Latex Rubber Gloves From Malaysia

Dear Mr. Roster:

This ruling is on a protest that was filed against your decision of July 22, 1994, in the liquidation of an entry covering ambidextrous disposable natural latex rubber examination gloves From Malaysia.

FACTS:

The articles under consideration are disposable unsterilized latex rubber examination gloves produced in Malaysia.

ISSUE:

What is the classification of disposable ambidextrous natural latex rubber examination gloves?

LAW AND ANALYSIS:

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 headings and any relative section and chapter notes. If GRI 1 fails to classify the goods and if the headings 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 not medical gloves and that they should be classified under subheading 4015.19.1010, HTSUSA, as other gloves.

Counsel notes that the gloves are packaged in dispenser boxes of 100 gloves which are marked "For Industrial Use Only" and are sold to various non-medical industries, i.e., electronic, pharmaceutical, food processing and chemical. Reference is made to regulatory provision of the Food and Drug Administration (FDA) and the Explanatory Notes (EN) to the Harmonized System regarding surgeon's gloves and the requirement that they be sterile. In this regard, we note that surgeon's gloves are used during an operation to protect a surgical wound from contamination, while the subject gloves are not surgeon's gloves but are examination gloves. Such 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 protestant's gloves.

Counsel notes that it is not economically practical to use the instant gloves for medical purposes. It is noted that increased factory inspection and FDA documentation cause medical and surgical gloves to cost more than industrial use gloves. We recognize this difference in cost but do not believe it is the result of any inherent difference between latex gloves labelled as medical and those labelled as industrial. As noted by counsel this cost difference is related to the costs resulting from meeting FDA procedures and requirements to permit latex gloves to be imported as medical gloves if the importer wishes to do so. We, however, note that if the importer does not wish to import the gloves as medical gloves but as industrial gloves, it need not follow the FDA procedures and requirements. This does not mean that there is substantive distinction between the gloves based on such labelling. We were unable to find any difference between gloves such as those which are the subject of this protest and examination gloves commonly seen in a physician's office. Absent documentation which confirms that there is a difference between examination gloves used for medical purposes and examination gloves that are used for other purposes, we must presume that they are the same.

Counsel notes that Customs has not discussed the elements of principal use and that such factor along with manner of labelling must be considered in classifying the gloves. Counsel indicates - 3 -
that certain commercial factors, as enunciated by the court in United States v. The Carborundum Company, 63 C.C.P.A. 98, C.A.D. 1172, 536 F.2d 373 (1976), cert. denied 429 U.S. 979 (1976) should be considered in defining a class or kind of merchandise. The factors specified therein are: the expectation of the ultimate purchaser; channels of trade; general physical characteristics, environment of sale (accompanying accessories, manner of advertisement and display); economic practicality of so using the import; and recognition in the trade of this use. Counsel concludes that based on these factors, it is evident that the instant gloves are not of the class or kind used for surgical or medical purposes. We disagree with counsel's conclusion. We have been unable, as previously noted, to confirm a difference between the physical characteristics of the "medical" versus the "non-medical" gloves.

We note that these gloves, regardless of their labelling or end use, are generally produced in the same FDA approved facilities, on the same machines, etc. In the past when we have submitted these gloves to laboratory analysis, they have all met the FDA requirements; although only certain of the gloves actually were FDA approved. Thus, we have no basis for concluding that there is a distinction between latex rubber gloves based on how they are labelled. This distinction appears to be \based on the importer marketing plan rather than any physical characteristics of the gloves. Thus, if we were to rely on the commercial designation and use, as suggested by counsel, we would have to conclude that two gloves which were exactly the same in all particulars, except that one was labelled "medical" and the other was labelled "non-medical" would not be uniformly classified.

Further, in classifying merchandise we read through the headings and subheadings until we reach the one that first describes the goods. Since the instant gloves meet the requirements for surgical and medical gloves, albeit not labelled as such, we have concluded that the prior classification, which follows the holding in Headquarters Ruling Letters (HRL) 951204 and 951586, dated June 23, 1992, and HRL 951489, dated July 1, 1992, is correct.

HOLDING:

Ambidextrous disposable natural latex rubber gloves, the product of Malaysia, are classifiable under subheading 4015.11.0000, HTSUSA, and were subject to a column 1 general rate of duty of 3.7 percent ad valorem in 1994.] - 4 -

Since the classification indicated above is the same as the classification under which the entry was liquidated, you are instructed to deny the protest in full.

A copy of this decision should be attached to the Customs Form 19 and provided to the protestant as part of the notice of action on the protest.

In accordance with Section 3A(11)(b) of Customs Directive 099 3553-065, dated August 4, 1993, Subject, Revised Protest Directive, this decision should be provided by your office to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entries in accordance with this decision must be accomplished prior to the mailing of the decision. Sixty days from the date of the decision the Office of Regulations and Rulings will take steps to make the decision available to Customs personnel via the Customs Rulings Module in ACS and the public via the Diskette Subscription Service, Freedom of Information Act and other public access channels.

Sincerely,

John Durant, Director
Commercial Rulings Division

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