HQ 963746

May 16, 2001

CLA-2 RR:CR:GC 963746 AM

**CATEGORY:** CLASSIFICATION

**TARIFF NO.:** 4015.19.10

Port Director

U.S. Customs Service

C/o Chief, Residual Liquidation and Protest Branch

6 World Trade Center, Room 761

New York, NY 10048-0945

**Re:** Protest 1001-99-100923; latex gloves

Dear Port Director:

This is in reference to protest 1001-99-100923 concerning the
classification, under the Harmonized Tariff Schedule of the United
States (HTSUS), of latex rubber gloves. The merchandise was entered on
March 17, 1998, and the entry was liquidated on January 29, 1999, under
subheading 4015.19.00, HTSUS, as other latex gloves. A protest was
timely filed on February 24, 1999.

In reviewing this protest, we reconsidered Customs Headquarters rulings
(HQs) 951033, dated June 8, 1992; 951586, dated June 23, 1992; 957522
and 957561, both dated May 24, 1995; and 961270, dated April 15, 1998,
all of which concerned the classification of rubber gloves. After
careful consideration, in accordance with 19 U.S.C. 1625(c), in HQ
964836, 964837, 964838, and 964839, dated May 2, 2001, (published in the
May 16, 2001 [Customs Bulletin]{.smallcaps}, Vol. 35, No. 20), we
revoked HQs 951033, 951586, 957522, and, 957561 and 961270.

**FACTS:**

The subject merchandise is pre-powdered and powder free seamless,
disposable latex rubber gloves (gloves) from Malaysia in one hundred
(100) count dispenser boxes. The boxes are labeled \"for industrial
use.\" The importer states that these latex gloves are marketed and sold
only for industrial use and in the food service industry.

**ISSUE:**

How are pre-powdered and powder free seamless, disposable latex rubber
gloves imported in one hundred count dispenser boxes for sale to
industrial and food service industries classified?

**LAW AND ANALYSIS:**

Merchandise imported into the U.S. is classified under the HTSUS. Tariff
classification is governed by the principles set forth in the General
Rules of Interpretation (GRIs) and, in the absence of special language
or context that requires otherwise, by the Additional U.S. Rules of
Interpretation. The GRIs and the Additional U.S. Rules of Interpretation
are part of the HTSUS and are to be considered statutory provisions of
law.

GRI 1 requires that classification be determined first according to the
terms of the headings of the tariff schedule and any relative section or
chapter notes and, unless otherwise required, according to the remaining
GRIs taken in order. GRI 6 requires that the classification of goods in
the subheadings of headings shall be determined according to the terms
of those subheadings, any related subheading notes and *mutatis
mutandis*, to the GRIs. In interpreting the HTSUS, the Explanatory Notes
(ENs) of the Harmonized Commodity Description and Coding System may be
utilized. The ENs, although not dispositive or legally binding, provide
a commentary on the scope of each heading, and are (official
interpretation of the Harmonized System at the international level)
generally indicative of the proper interpretation of the HTSUS. *See*
T.D. 89‑80, 54 Fed. Reg. 35127 (August 23, 1989).

Additional U.S. Rule of Interpretation 1(a) requires that \"a tariff
classification controlled by use (other than actual use) is to be
determined in accordance with the use in the United States at, or
immediately prior to, the date of importation, of goods of that class or
kind to which the imported goods belong, and the controlling use is the
principal use\".

The following HTSUS provisions are under consideration:

4015 Articles of apparel and clothing accessories (including gloves),
for all purposes, of vulcanized rubber other than hard rubber:

Gloves:

4015.11.00 Surgical and medical

\* \* \* \* \*

4015.19 Other:

4015.19.10 Seamless

The EN for subheading 4015.11, states as follows: \"\[S\]urgical gloves
are thin, highly tear-resistant articles manufactured by immersion, of a
kind worn by surgeons. They are generally presented in sterile packs.\"

Subheading 4015.11, HTSUS, is a principal use provision. The court in
*E. M. Chemicals v. United States*, 20 C.I.T. 382, 923 F. Supp. 202
(1996 Ct. Intl. Trade) explained the application of these types of HTSUS
provisions thus:

> When applying a \"principal use\" provision, the Court must ascertain
> the class or kind of goods which are involved and decide whether the
> subject merchandise is a member of that class. See *supra* Additional
> US Rule of Interpretation 1 to the HTSUS. In determining the class or
> kind of goods, the Court examines factors which may include: (1) the
> general physical characteristics of the merchandise; (2) the
> expectation of the ultimate purchasers; (3) the channels of trade in
> which the merchandise moves; (4) the environment of the sale (e.g.,
> the manner in which the merchandise is advertised and displayed); (5)
> the usage of the merchandise; (6) the economic practicality of so
> using the import; and (7) the recognition in the trade of this use.
> *United States v. Carborundum Co*., 63 C.C.P.A. 98, 102, 536 F.2d 373,
> 377, cert. denied, 429 U.S. 979, 50 L. Ed. 2d 587, 97 S. Ct. 490
> (1976); see also *Lenox Coll.*, 20 C.I.T., Slip Op. 96-30, at page 5.

Our decisions in HQs 951033, 951586, 957522, 957561, and 961270,
classifying disposable latex gloves for industrial use in subheading
4015.11.00, HTSUS, the provision for surgical and medical latex gloves,
were based on the premise that industrial use gloves and medical use
gloves are actually the same product and hence belong to the same class
or kind of merchandise. In those rulings, we noted that both industrial
use and medical use gloves were made on the same machines and of the
same materials. We went on to state that: \"there does not appear to be
any basis for distinguishing between these gloves and medical use latex
gloves.\" We now believe this statement is in error.

At the outset, we note that, if non-medical use gloves and medical use
gloves belong to the same class or kind of merchandise, then it is no
more incumbent upon Customs to classify all latex gloves as \"surgical
and medical\" gloves than it would be to classify all the gloves as
\"other latex gloves.\" In fact, latex gloves which bear the medical use
label are sold by the same retailers and used in the same way as general
purpose non-medical use gloves, thus, the applicable class or kind of
goods to which all latex gloves would belong if we considered them as
one is \"other latex gloves\" rather than \"surgical and medical\"
gloves.

In fact, the international language of the tariff does not refer to
medical gloves at all. Through historical happenstance, the term
\"Surgical and medical\" was carried over from the Tariff Schedule of
the United States (\"TSUS\"), the precursor to the HTSUS, to subheading
4015.11, HTSUS. The U.S. International Trade Commission is considering
bringing the HTSUS in conformity with the international language.
Nevertheless, we must interpret the language of the HTSUS as presently
worded.

Although the text of the EN seems to relate only to \"surgical gloves,\"
given the history noted above, it is at least ambiguous whether EN
4015.11 applies to only surgical gloves, or whether, in the HTSUS, where
the subheading is entitled \"surgical and medical\", Congress intended
for the EN to apply to both terms. Regardless, there is a general
concern, elicited by the EN, that the gloves classified in subheading
4015.11 be of a quality different from those classified as \"other\"
latex gloves. In the United States, that quality difference is governed
by Food and Drug Administration (\"FDA\") regulations, which, in turn,
governs the use of the gloves. Such gloves undergo stringent testing of
their leak resistance and adulteration. (21 CFR 800.20). According to a
source at the FDA, industrial use gloves are latex gloves that have
failed this test or were not tested. Manufacturers may then sell the
untested, adulterated or leaky gloves to the cosmetic, food handling,
electronic and other industries. There are strict penalties for
attempting to insert industrial use gloves into the medical use market
because they are of differing quality. (21 CFR 800.55). The quality
difference and marketing of these gloves, where the tear resistance of
the article is specifically noted in the EN, distinguishes the surgical
and medical use gloves from the non-medical use gloves.

Correct application of the *Carborundum* factors, the legal standard for
analysis of principal use provisions, reveals distinctions between
medical and non-medical use latex gloves based on real differences in
the use of the gloves, whether or not any particular glove, from a box
labeled \"not for medical use\" could theoretically form an effective
barrier against blood-borne pathogens and other bodily fluids.

1.  The general physical characteristics of a lot of non-medical use
    gloves may include a higher percentage of leaks, tears or pinholes
    than found in medical use gloves. While any particular non-medical
    use glove is likely to be physically exactly the same as a medical
    use glove, the imported product is non-medical use gloves packaged
    for retail sale. A given box of non-medical use gloves likely
    contains a higher number of defective gloves than a given box of
    medical use gloves.

2.  The expectation of the ultimate purchaser of medical gloves is that
    the glove serves as an effective barrier between blood-borne
    pathogens that may be lethal, and the wearers skin. The expectation
    of the purchaser of non-medical use gloves is that the gloves will
    protect the wearer against chemicals and other irritants and will
    create a generally hygienic environment for handling food, cosmetics
    and other products. Expectations about the quality of the glove are
    much higher among the ultimate purchasers of medical use gloves. So
    much so, that the FDA has proposed a new rule requiring additional
    testing of the tear resistance and degradation potential of medical
    use gloves due to consumer concerns about the quality of medical use
    gloves (64 FR 41710, July 30, 1999). In fact, testing a particular
    lot of gloves for labeling as medical use gloves increases the
    marketing potential of the gloves because the ultimate purchaser
    prefers the assurance of a high quality product.

3.  Medical use gloves follow channels of trade to clinical settings.
    Although non-medical use gloves are sold through the same retailers
    as some medical use gloves, non-medical use gloves do not enter the
    same industries as medical use gloves. Medical use gloves appear in
    clinical settings where non-medical use gloves are prohibited from
    use under FDA guidelines (21 CFR 801 *et seq.*). Although another
    agency\'s regulations are not controlling in Customs classification
    decisions, where Customs must apply a \"use\" provision to
    merchandise, the controlling regulatory scheme is indeed relevant.

4.  The environment of the sale includes a label stating that
    non-medical use gloves are only for industrial use or for
    non-medical use. Medical use gloves have greater consumer appeal
    because of their assurance of quality and are marketed accordingly.

5.  The actual usage of gloves labeled specifically for non-medical use
    can not be a medical use because such use is prohibited by the FDA
    (21 CFR 801 *et seq.*).

6.  There is a slight cost difference in medical and non-medical use
    gloves but, this may not interfere with the use of medical gloves as
    non-medical use gloves. However, the proposed new rule by the FDA,
    which would require additional testing of medical use gloves, may
    again make using medical use latex gloves as industrial or general
    purpose latex gloves prohibitive due to the difference in cost of
    the gloves. Nevertheless, the cost difference is not the only factor
    to consider.

7.  The recognition in the trade of industrial use is apparent by the
    labeling \"not for medical use.\"

On balance, application of the *Carborundum* factors reveals that the
correct classification for gloves imported for and labeled for
non-medical use is in subheading 4015.19.10, the provision for
\"\[A\]rticles of apparel and clothing accessories (including gloves),
for all purposes, of vulcanized rubber other than hard rubber:
\[G\]loves: \[O\]ther: \[S\]eamless\".

**HOLDING:**

Latex gloves labeled for non-medical use are classified in subheading
4015.19.10, HTSUS, the provision for \"\[A\]rticles of apparel and
clothing accessories (including gloves), for all purposes, of vulcanized
rubber other than hard rubber: \[G\]loves: \[O\]ther: \[S\]eamless.\"
The protest is DENIED.

In accordance with Section 3A(11)(b) of Customs Directive 099 3550‑065,
dated August 4, 1993, Subject: Revised Protest Directive, you are to
mail this decision, together with the Customs Form 19, to the protestant
no later than 60 days from the date of this letter. Any reliquidation of
the entry or entries in accordance with the decision must be
accomplished prior to mailing the decision.

Sixty days from the date of the decision, the Office of Regulations and
Rulings will make the decision available to Customs personnel, and to
the public on the Customs Home Page on the World Wide Web at
[www.customs.gov](http://www.customs.ustreas.gov/), by means of the
Freedom of Information Act, and other methods of public distribution.

Sincerely,

John Durant, Director

Commercial Rulings Division