CLA-2 R:C:F 957522 ALS

District Director of Customs
1000 Second Ave, Room 2200
Seattle, WA 98104

RE: Request for Further Review of Protest 3001-94-100631, dated October 24, 1994, Concerning Disposable Latex Rubber Examination Gloves From Malaysia

Dear Mr. Hardy:

This ruling is on a protest that was filed against your decision of October 21, 1994, in the liquidation of an entry covering the referenced articles.


The articles under consideration are ambidextrous disposable unsterilized latex examination gloves produced in Malaysia which are imported in bulk and subsequently packaged in quantities of 100 pieces.


What is the classification of ambidextrous natural latex disposable rubber examination 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 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. - 2 -

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 non medical gloves classifiable in subheading 4015.19.1010, HTSUSA. The protestant states that the subject gloves, which are imported in bulk, are not medical gloves and that, when repackaged after importation, they are labelled as non-medical gloves. A photocopy of a portion of that pacakage is provided to confirm that.

The protestant notes that the gloves are not approved by the Food and Drug Administration (FDA) for medical purposes. It also notes that, while the gloves are manufactured in a facility approved by the FDA under its Good Manufacturing Practices, they do not meet the FDA requirements for medical gloves. In this regard the protestant notes that the non-medical character of the gloves can be tested by viewing the pricing, labelling and packaging, advertising and customer lists. It also notes that the commercial designation of the merchandise and the FDA standards should be used in interpreting the tariff. It further states that there may be different production lines or facilities in an FDA approved facility and that gloves in such a facility may be produced by a Taiwanese machine which may produce products which do not pass pinhole ratio requirements.

In considering this matter we note that latex examination gloves, as indicated in Headquarters Ruling Letters (HRL) 951204 and 951586, dated June 23, 1992 and HRL 951489, dated July 1, 1992, need only meet FDA standards if they are to be marketed as medical gloves. In such case the gloves would have to be manufactured pursuant to FDA requirements and regulations, as noted by the protestant. While the protestant indicates that there are secondary facts such as price, packaging, labelling, etc., which should be used to corroborate whether the gloves are medical or non-medical, we do not believe that these factors are conclusive. The protestant clearly notes that the price for medical gloves is almost double the price paid for non-medical latex gloves. It also notes that gloves for medical purposes must comply with costly FDA approval procedures. Since the protestant has not provided any objective documentation or information which would permit us to distinguish between the medical and non-medical gloves and since the procedures for obtaining FDA approval are obviously costly, we must assume that the increased costs of the gloves labelled medical gloves is related to meeting FDA requirements relating to facility approval, testing, etc., so that certain gloves can be marketed as medical gloves. In other words no objective documentation or information has been submitted which would provide a basis for - 3 -

distinguishing between those gloves which are to be marketed for medical purposes and which, therefore, must comply with FDA requirements, and those gloves which are to be marketed for other purposes and which, therefore, need not comply with FDA requirements and are not submitted for such approval. In view of this, the fact that Customs laboratory analysis confirms that the instant gloves meet the FDA standards, along with the fact that the gloves are manufactured in an FDA approved facility by a registered supplier of medical gloves, etc., makes it difficult to reach a conclusion other than these are medical gloves.

We have seen dispenser boxes of latex examination gloves in both medical and commercial environments and have been unable to observe a difference between the two except as to labelling. They would both seem to be capable of accomplishing the purposes for which they were manufactured, preventing the transmittal of disease or contamination between the examiner and the object of the examination. Based on the documentation of record in this protest and after reviewing the documentation submitted in connection with earlier rulings, we have been unable to conclude that the instant gloves are somehow distinguishable from medical gloves except for the method in which they are labelled and marketed.

While the use of a product in the United States might be considered in determining the classification of a product, we do not agree with the protestant that the common or commercial definition of the product in the United States, based on whether or not the importer, manufacturer, or other interested party has sought FDA approval of certain latex gloves as medical gloves, is controlling for tariff purposes. If we were to follow this argument 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 apparently meet the requirements for surgical and medical gloves, albeit not labelled as such, we have concluded that the prior classification is correct.


Ambidextrous disposable latex examination gloves, the product of Malaysia, are classifiable under subheading 4015.11.0000, HTSUSA, and were subject to a column one general rate of duty of 3.7 percent ad valorem. - 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.


John Durant, Director
Commercial Rulings Division