CLA-2 CO:R:C:F 951204 ALS
District Director of Customs
1 East Bay Street
Savannah, Georgia 31401
RE: Request for Further Review of Protest 1704-91-100301, dated
November 7, 1991, Concerning Ambidextrous Disposable Latex
Rubber Examination Gloves
Dear Mr. Richter:
This ruling is on a protest that was filed against your
decisions of August 9, 1991, in the liquidations of several entries
covering the referenced articles.
FACTS:
The articles under consideration are disposable unsterilized
latex examination gloves produced in Malaysia which are
approximately 9-1/2 inches in length. They are ambidextrous and
are produced in three sizes: small, medium and large. They are
lightly powdered to facilitate their placement on a user's hands.
They are packaged in dispenser boxes that hold one hundred gloves.
ISSUE:
What is the classification of ambidextrous natural latex
disposable 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.
- 2 -
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 not medical
gloves and that they should be classified under subheading
4015.19.1010, HTSUSA, as other gloves. Counsel states that
subheading 4015.11, HTSUSA, does not apply to non-sterile exam
gloves which are used in a more generalized healthcare situation
or elsewhere. Counsel states that "medical or surgical gloves
utilized for body-intrusive procedure must be sterilized and are
usually procedure specific...." According to counsel such gloves
are only considered medical if they are "...manufactured as and
used primarily by physicians while performing medical tasks and
used primarily for the protection of the patient. Use in a general
healthcare environment is insufficient for classification under
this provision."
In considering this matter we consulted the Explanatory Notes
to the Harmonized System which represent the opinion of the
international classification experts, but are not legally binding.
The subheading explanatory note to subheading 4015.11 thereof
described 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. 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. 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 surgeons' gloves; adulteration. These regulations,
written in light of the prevalence of human immunodeficiency virus
(HIV) infections and applicable to all medical and surgical gloves,
define adulteration of the referenced gloves and establish the
sample plans and test method to be used to determine if the gloves
are adulterated.
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 - 3 -
finger to prevent contamination between patient and examiner."
Section 880.4460, FDA Regulations (21 CFR 880.4460) 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
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 discussions 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 the gloves which
are the subject of this protest and those 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 a disease and assure that a
disease will not be transmitted from one patient to another via
the physician are satisfactory for this purpose.
In further considering the documents of record, we noted that
the supplier's invoice to the protestant indicates that the gloves:
(1) Are listed with the FDA on Product Listing Document
#444401
(2) Conform to specification G109-887-07 dated: 15-08-1990
(3) Have the FDA's 510(K) letter, K891255 of "SUBSTANTIAL
EQUIVALENCE" finalized and dated April 13, 1989
The aforementioned FDA sources advised us that these documents
relate only to various aspects of medical glove approval. They
noted that they would not be interested in the - 4 -
gloves unless such gloves were declared to be medical gloves. The
presentation of these shipments to FDA for clearance at the time
of importation on FDA Form 702, further confirms that these gloves
were considered medical gloves at the time of importation.
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 noted that protestant has not provided any objective basis
for distinguishing its product from those which are labelled
medical gloves. Other than statements, made in the protest that
the gloves would be used for non-medical purposes, which conflict
with previously noted documentary information, there does not
appear to be any basis for distinguishing these gloves from those
described as medical gloves.
HOLDING:
Ambidextrous disposable 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 a part
of the notice of action on the protest.
Sincerely,
John Durant, Director
Commercial Rulings Division