CLA-2 CO:R:C:F 951033 ALS
District Director of Customs
55 Erieview Plaza
Cleveland, Ohio 44114
RE: Request for Further Review of Protest 4103-91-000187, dated
June 13, 1991, Concerning Disposable Latex Rubber Gloves
Dear Mr. Nelson:
This ruling is on a protest that was filed against your
decision of May 17, 1991, in the liquidation of several entries
covering the referenced items. Other protests covering the same
or similar gloves were also filed. Consideration of this matter
was delayed since one or more of the protest files were misdirected
during processing.
FACTS:
The articles under consideration are two styles of disposable
latex gloves. One style is ambidextrous, powdered for easy on-
off, comes in 9-1/2 inch length and .005 inch thickness and comes
in two sizes. It is packaged in boxes of 100 and in polybags of
1000. The sample box provided has a stick-on label bearing the
legend "FOR INDUSTRIAL USE". Advertising literature provided by
the protestant specifies a number of uses for the gloves and states
that they are for use "[a]nywhere you need a light duty liquidproof
glove." Information on the box specifies that the gloves are made
from natural latex for greater finger dexterity extra sensitivity
and tactility, they do not cause hand fatigue, they have snug
rolled cuffs for greater protection and they keep hands cool and
comfortable.
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A second style of the latex gloves is made for both left hand
and right hand application. They come in a 12 inch length, are
.009 inches thick, have an anti-slip bisque finish and come in
half-sizes ranging from 6 to 9. Some of the gloves and are
packaged in an individual heat-sealed polybag and some are packaged
50 right-hand or left-hand gloves per heat-sealed polybag. Both
of the aforementioned packages are subsequently packaged in master
heat sealed polybags which, in turn, are packaged so that there are
200 pairs per case. These gloves are noted to provide a
combination of comfort, sensitivity and fit, offer a secure grip
for both wet and dry applications and to provide one of the
industry's lowest particulate levels for use in a clean room
environment.
ISSUE:
What is the classification of 100 percent natural latex
disposable rubber 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
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 industrial
gloves classifiable under subheading 4015.19.1010, HTSUSA. The
protestant notes that these gloves are labelled for industrial use
and that they are sold to distributors who sell to industrial
companies for various applications. Advertising literature
provided by the protestant states that the ambidextrous gloves are
good "[a]nywhere you need a light-duty liquidproof glove" and
specifies use in laboratory analysis/technical work, food
processing and handling, quality control, electronic assembly,
polishing, equipment clean-up, nuclear power plant clean-up,
pharmaceutical plants, cosmetic manufacturing, semi-conductor
plans, acid etching, camera lens and film processing, watch
manufacturing, medical kit manufacturing, biotechnology, airline
cabin maintenance, USDA veterinary departments, fast-food - 3 -
preparation and quality control inspection. Similar advertising
literature regarding the gloves which are specifically designed
for left or right hand application states that such gloves are for
use in electronics, pharmaceuticals, aerospace and biotech
controlled environments and in environments where there is a need
for reduced particle contamination.
The protestant also states that the gloves are marked "FOR
INDUSTRIAL USE" in order to comply with the Food and Drug
Administration (FDA) requirements for disposable rubber latex
gloves used with industrial applications.
In considering this matter we consulted the Explanatory Notes
to the Harmonized System which represents the opinion of the
international classification experts. We noted that the subheading
explanatory note to subheading 4015.11 describes surgical gloves
as "...thin, highly tear-resistant article manufactured by
immersion, of a kind worn by surgeons. They are generally
presented in sterile packs."
We also consulted the regulations of the FDA. 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. A FDA
source informally advised us that that agency would not be
interested in latex gloves being brought in for non-medical
purposes. He was unable to confirm that such a regulation existed.
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 adulterated. Those
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 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 to protect a surgical wound from
contamination." While there is no FDA - 4 -
regulatory requirement that these gloves be sterile, FDA guidelines
do provide that gloves utilized during operating procedures meet
certain sterility requirements. The aforementioned FDA source
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 an FDA source 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 protestants ambidextrous gloves.
We were unable to distinguish any difference between such
gloves which are the subject of this protest and those which were
observed in the physician's office.
The 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.
While the FDA Regulations are not binding on the Customs
Service and are referenced for information purposes only, we noted
that those regulations, while defining qualities to be possessed
by the surgeon's and examination gloves, did not provide any
characteristics which would be unique to those gloves. We also
noted that the documentation provided by the protestant did not
provide any basis for distinguishing between its product and
medical gloves. Other than statements that the gloves would be
used for industrial purposes and a label, stick-on in the case of
the ambidextrous gloves, which stated they were for industrial use,
there does not appear to be any basis for distinguishing these
gloves from those described as medical gloves.
HOLDING:
The subject disposable latex gloves are classifiable under
subheading 4015.11.0000, HTSUSA, and are subject to a general rate
of duty of 3.7 percent ad valorem. Such articles, if the
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product of Thailand, which meet the requirements of General Note
3(c)(ii) of the HTSUSA, regarding the General System of Preferences
(GSP), are eligible for a free special rate of duty upon compliance
with the provisions of section 10.171 et seq., Customs Regulations
(19 CFR 10.171 et seq.). Such articles, if the product of
Malaysia, are presently excluded from such treatment by subdivision
(c)(ii)(D) of General Note 3, HTSUSA.
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