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