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.
FACTS:
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.
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.
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.
HOLDING:
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.
Sincerely,
John Durant, Director
Commercial Rulings Division