CLA-2 CO:R:C:F 951489 ALS

District Director of Customs
40 South Gay Street
Baltimore, Maryland 21202

RE: Request for Further Review of Protest 1303-91-100402, dated November 26, 1991, Concerning Ambidextrous Disposable Latex Rubber Examination Gloves

Dear Mr. Beikirch:

This ruling is on a protest that was filed against your decisions of August 30, 1991, in the liquidations of several entries covering the referenced articles.


The articles under consideration are disposable unsterilized latex examination gloves produced in Malaysia which are approximately 9 inches in length. They are ambidextrous and are packages in boxes of 100.


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 heading and any relative section - 2 -

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 gloves are not medical gloves and that they should be classified under subheading 4015.19.1010, HTSUSA. The protestant states that, in the industry, medical gloves are "sterile" and other protective gloves labelled "non- sterile" are utilized for protection from a number of outside skin problems. The protestant also states that sterile gloves protect the patient and the wearer, which is important in the medical field, and that non-sterile exam gloves protect only the wearer. The protestant notes that it sells sterile medical latex gloves to the medical field and that hospitals also buy some non-sterile bulk latex gloves to protect the wearers. It notes that medical gloves, referred to as floor or surgical gloves, within the industry, are high grade/high quality, sterile gloves which would be used for surgical or body contact, medical procedures. It notes that exam or examination gloves describe non-sterile low grade/low quality gloves which would be used for general protection and cleanliness by print shops, police, hospital cleaning staffs, beauty shops, etc. In considering the matter, we consulted the Explanatory Notes to the Harmonized System which represent the opinion of the international classification experts. We noted that subheading explanatory note to subheading 4015.11 describes surgical gloves as "...thin, highly tear-resistant articles manufactured by immersion, of a kind worn by surgeons. They are generally presented in sterile packs." No provision is presented therein as to patient examination gloves.

We also consulted the regulations of the Food and Drug Administration (FDA). In this regard, we were unable to confirm that there is a regulation of that agency which requires the labelling of gloves for non-medical purposes. Several FDA sources informally advised us that that agency would not be interested in latex gloves being brought in for non-medical purposes. 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 - 3 -

adulterated. These 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 patient 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 protect a surgical wound from contamination." While there is no FDA regulatory requirement that these gloves be sterile, FDA guidelines do provide that gloves utilized during operating procedures meet certain sterility requirements. The aforementioned FDA sources 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 discussion with both FDA sources 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 protestant's ambidextrous gloves.

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.

The above-noted 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 disease and assure that a disease will not be transmitted from one patient to another via the physician are satisfactory for this purposes. While the protestant states that the subject gloves are not medical gloves and the FDA has advised us that they would not be interested in non-medical gloves, it is noted that the documents of record indicate that at least some of the shipments of the subject gloves were presented for FDA clearance on FDA Form 702 - 4 -

at the time of importation. This further confirms that these gloves were considered medical gloves at that time.

While neither the FDA Regulations nor FDA actions are binding on the Customs Service and are referenced for information purposes only, we note that those regulations and actions do not provide any basis for distinguishing medical gloves from non-medical gloves. We also note that the documentation provided by the protestant, while indicating that medical gloves may be packaged in different ways, did not provide any basis for distinguishing between its product and medical gloves. Other than statements, made in the protest, that the gloves would be used for non-medical purposes, which conflicts with information and documents of record, there does not appear to be any basis for distinguishing the gloves which are the subject of the protest from those described as medical gloves.


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

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