CLA-2 R:C:F 957561 ALS
District Director of Customs
610 S. Canal Street
Chicago, IL 60607
RE: Request for Further Review of Protest 3901-94-102358,
dated October 20, 1994, Concerning Disposable Natural Latex
Rubber Gloves From Malaysia
Dear Mr. Roster:
This ruling is on a protest that was filed against your
decision of July 22, 1994, in the liquidation of an entry
covering ambidextrous disposable natural latex rubber examination
gloves From Malaysia.
FACTS:
The articles under consideration are disposable unsterilized
latex rubber examination gloves produced in Malaysia.
ISSUE:
What is the classification of disposable ambidextrous
natural latex 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 not medical
gloves and that they should be classified under subheading
4015.19.1010, HTSUSA, as other gloves.
Counsel notes that the gloves are packaged in dispenser
boxes of 100 gloves which are marked "For Industrial Use Only"
and are sold to various non-medical industries, i.e., electronic,
pharmaceutical, food processing and chemical. Reference is made
to regulatory provision of the Food and Drug Administration (FDA)
and the Explanatory Notes (EN) to the Harmonized System regarding
surgeon's gloves and the requirement that they be sterile. In
this regard, we note that surgeon's gloves are used during an
operation to protect a surgical wound from contamination, while
the subject gloves are not surgeon's gloves but are examination
gloves. Such 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 gloves.
Counsel notes that it is not economically practical to use
the instant gloves for medical purposes. It is noted that
increased factory inspection and FDA documentation cause medical
and surgical gloves to cost more than industrial use gloves. We
recognize this difference in cost but do not believe it is the
result of any inherent difference between latex gloves labelled
as medical and those labelled as industrial. As noted by counsel
this cost difference is related to the costs resulting from
meeting FDA procedures and requirements to permit latex gloves to
be imported as medical gloves if the importer wishes to do so.
We, however, note that if the importer does not wish to import
the gloves as medical gloves but as industrial gloves, it need
not follow the FDA procedures and requirements. This does not
mean that there is substantive distinction between the gloves
based on such labelling. 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. Absent documentation which confirms that there is a
difference between examination gloves used for medical purposes
and examination gloves that are used for other purposes, we must
presume that they are the same.
Counsel notes that Customs has not discussed the elements of
principal use and that such factor along with manner of labelling
must be considered in classifying the gloves. Counsel indicates - 3 -
that certain commercial factors, as enunciated by the court in
United States v. The Carborundum Company, 63 C.C.P.A. 98, C.A.D.
1172, 536 F.2d 373 (1976), cert. denied 429 U.S. 979 (1976)
should be considered in defining a class or kind of merchandise.
The factors specified therein are: the expectation of the
ultimate purchaser; channels of trade; general physical
characteristics, environment of sale (accompanying accessories,
manner of advertisement and display); economic practicality of so
using the import; and recognition in the trade of this use.
Counsel concludes that based on these factors, it is evident that
the instant gloves are not of the class or kind used for surgical
or medical purposes. We disagree with counsel's conclusion. We
have been unable, as previously noted, to confirm a difference
between the physical characteristics of the "medical" versus the
"non-medical" gloves.
We note that these gloves, regardless of their labelling or
end use, are generally produced in the same FDA approved
facilities, on the same machines, etc. In the past when we have
submitted these gloves to laboratory analysis, they have all met
the FDA requirements; although only certain of the gloves
actually were FDA approved. Thus, we have no basis for
concluding that there is a distinction between latex rubber
gloves based on how they are labelled. This distinction appears
to be \based on the importer marketing plan rather than any
physical characteristics of the gloves. Thus, if we were to rely
on the commercial designation and use, as suggested by counsel,
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 meet the
requirements for surgical and medical gloves, albeit not labelled
as such, we have concluded that the prior classification, which
follows the holding in Headquarters Ruling Letters (HRL) 951204
and 951586, dated June 23, 1992, and HRL 951489, dated July 1,
1992, is correct.
HOLDING:
Ambidextrous disposable natural latex rubber gloves, the
product of Malaysia, are classifiable under subheading
4015.11.0000, HTSUSA, and were subject to a column 1 general rate
of duty of 3.7 percent ad valorem in 1994.] - 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