OT:RR:CTF:CPMMA H320116 RFC
Center Director
Apparel, Footwear and Textile Center for Excellence and Expertise
U.S. Customs and Border Protection
33 New Montgomery Street, 16th Floor
San Francisco, CA 94105
ATTN: Christina Howard-Ceterski, Import Specialist
RE: Protest and AFR No. 2006-21-106118; Classification of Disposable Nitrile Gloves
Dear Center Director:
The following is our decision regarding the Application for Further Review
(“AFR”) of Protest Number 2006-21-106118, timely filed on February 9, 2021, by
Carmichael International Service on behalf of Shen Wei USA Inc. (“Protestant”). This
AFR concerns the classification by U.S. Customs and Border Protection (“CBP”), under
the Harmonized Tariff Schedule of the United States (“HTSUS”) (2019), of disposable
nitrile gloves.
By way of a November 14, 2022, email message, new counsel of record
(Sandler, Travis & Rosenberg, P.A.), who replaced the previous counsel of record
(Junker & Nakachi, P.C.), submitted an undated and unsigned document entitled
“Supplement to Protest No. 200-21-106118.” At the request of the new counsel of
record, a virtual conference was held on November 28, 2022, with representatives of
CBP and representatives of the protestant to discuss the instant protest. A PowerPoint
presentation was shown during the conference and a copy was submitted for review.
FACTS:
The merchandise that is the subject of this protest is disposable nitrile gloves.
There are seven (7) different gloves identified in the Customs Protest and Summons
Information Report (Customs Form 6445A) (dated February 9, 2021):
• Nitrile Glove 1: Item #N772351-56, Style Megaman (Blue), Aka Powerform S12+;
• Nitrile Glove 2: Item #N716882-6, Style Stellar S6, Aka Powerform;
• Nitrile Glove 3: Item #N260881-87, Style Megaman (Black);
• Nitrile Glove 4: Item #N106551-56, Style Hydrex, Aka Powerform;
• Nitrile Glove 5: Item #N027401-06, Style Powerform X5+, Aka Trueform;
• Nitrile Glove 6: Item #128401-05, Style Aloeform Soft, Aka Trueform; and
• Nitrile Glove 7: Item #N129401-06, Style Aloeform X6, Aka, Powerform.
The gloves are reportedly sold to distributors and not sold directly to end users. The
country of origin is China.
In a submission entitled “Administrative Protest” from the previous counsel of
record for the protestor, dated November 20, 2019, (with a cover letter dated February
9, 2021) in a section entitled “Factual Background,” a chart identifies all the gloves as
being made of nitrile and the product labels, product packaging and product marketing
as “examination gloves.” Furthermore, in the same section, it states, in part, as follows:
The subject merchandise involves five entries containing 8 models of nitril [sic]
medical examination gloves…These medical examination gloves are labeled as
such, on the packaging, they are marketed as examination gloves, and many
also state that they are for “medical use only”...The subject merchandise is
marked as for medical use as examination gloves…The specifications for the
subject merchandise meet the ASTM specifications for medical gloves found in
ASTM D6319-19…The subject merchandise (brands and models) have each
also obtained FDA pre-market 510(k) approval as being in conformance with the
FDA requirements and are therefore authorized for marketing and sale in the
United States as “medical” gloves…The gloves are active to distributors who are
active in the scientific community and whom market the gloves (labeled as Exam
gloves) accordingly as being for “medical” use.
On a website that sells the three types of disposable gloves that are the subject
of this protest (i.e., TrueForm disposable gloves, PowerForm disposable gloves, and
MegaMan disposable gloves) can be found the following descriptions and pictures of
the gloves:
TrueForm
TrueForm is made for those who rely on daily hand protection to provide ease of
use and high dexterity. With TrueForm, quality is designed into every single style
using exacting manufacturing processes for tip-to-cuff consistency, glove after
glove.
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PowerForm
PowerForm brings new hand protection technologies to workplace performance.
From sweat management to enhanced grip design, PowerForm features enable
workers to execute tasks with more confidence. PowerForm focuses on
functional advancements to optimize on-the-job performance every day.
MegaMan
MegaMan pushes the boundaries of single-use hand protection performance,
with new levels of abrasion resistance, sweat management, and comfort that
deliver in exceedingly severe environments. Reach for MegaMan on the toughest
jobs, when protection matters most.
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https://swsafety.com/single-use-gloves/ (Last visited on 30 November 2022)
On a website featuring the MegaMan N260881 glove (which is identified in the
protest submission), it states as follows:
MegaMan® N260881-XS Single-Use Silicone-Free Gloves, XS, Nitrile, Black, 11
in L, Powder-Free, Fully Textured, 10.1 mil THK, Application Type: Industrial,
Ambidextrous Hand (Emphasis added.)
https://www.arbill.com/2568872/product/n/megamanreg-n260881-xs (Last visited on 30
November 2022)
On another website there is a technical data sheet for the Megaman gloves; it lists
item number N260881 gloves and identifies the following applications for the gloves:
• Assembly
• Chemical Handling
• Fabrication
• Janitorial Maintenance
• Light Machining Operations
• Maintenance
• Waste Management
https://swsafety.com/wp-content/uploads/2020/09/MM-11BK-Datasheet.pdf (Last visited
on 30 November 2022).
The Food and Drug Administration has the following description with respect to
medical gloves:
About medical gloves
Medical gloves are examples of personal protective equipment that are used to
protect the wearer and/or the patient from the spread of infection or illness
during medical procedures and examinations. Medical gloves are one part of
an infection-control strategy. (Emphasis added.)
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Medical gloves are disposable and include examination gloves, surgical gloves,
and medical gloves for handling chemotherapy agents (chemotherapy gloves).
These gloves are regulated by the FDA as Class I reserved medical devices that
require a 510(k) premarket notification. FDA reviews these devices to ensure that
performance criteria such as leak resistance, tear resistance and biocompatibility
are met.
https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gloves
(Last visited on 30 November 2022).
The merchandise in the above-mentioned protest was entered by the importer in
10-digit statistical reporting number 4015.19.0550, HTSUSA (2019). A Notice of Action
(CBP Form 29) (dated August 10, 2020) was issued advising that the merchandise was
classified in 10-digit statistical reporting number 4015.19.1010, HTSUSA (2019). The
merchandise was liquidated in that 10-digit statistical reporting number. In the instant
protest, the protestant contends that the merchandise is properly classified in 10-digit
statistical reporting number 4015.19.0550, HTSUSA (2019) as medical gloves rather
than in 10-digit statistical reporting number 4015.19.1010, HTSUSA (2019) as other
than medical gloves.
ISSUE:
What is the proper classification of the subject merchandise under the HTSUS
(2019): (1) in subheading 4015.19.05, HTSUS, as medical gloves; or (2) in subheading
4015.19.10, HTSUS, as other than medical gloves?
LAW AND ANALYSIS:
The protest was properly filed as a decision on classification under 19 U.S.C. §
1514(a)(2). The protest was timely filed within 180 days of liquidation of the entry. See
19 U.S.C. § 1514(c)(3). Moreover, further review of the protest is properly accorded to
protestant pursuant to 19 CFR § 174.24(b) because the decision against which the
protest was filed is alleged to involve questions of law or fact which have not been ruled
upon by the Commissioner of Customs or his designee or by the Customs courts.
Merchandise imported into the United States is classified under the HTSUS. The
tariff classification of merchandise under the HTSUS is governed by the principles set
forth in the General Rules of Interpretation (“GRIs”) and, in the absence of special
language or context which otherwise requires, 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 provision of law for all purposes. See
Sections 1204(a) and 1204(c) of the Omnibus Trade and Competitiveness Act of 1988
(19 U.S.C. §§ 1204(a),(c)).
GRI 1 requires that classification be determined first according to the terms of the
headings of the tariff schedule (i.e., (1) merchandise is to be classified under the 4-digit
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heading that most specifically describes the merchandise; (2) only 4-digit headings are
comparable; and (3) merchandise must first satisfy the provisions of a 4-digit heading
before consideration is given to classification under a subheading within this 4-digit
heading) and any relative section or chapter notes and, provided such headings or
notes do not otherwise require, then according to the other GRIs.
GRI 6 prescribes that, for legal purposes, GRIs 1 to 5 shall govern, mutatis
mutandis, classification at subheading levels within the same heading. Therefore,
merchandise is to be classified at equal subheading levels (i.e., at the same digit level)
within the same 4-digit heading under the subheading that most specifically describes or
identifies the merchandise.
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 HTSUS (2019) subheadings at issue are as follows:
4015.19.0550: Articles of apparel and clothing accessories (including
gloves, mittens and mitts), for all purposes, of vulcanized
rubber other than hard rubber: Gloves, mittens and mitts:
Other: Medical, Other.
4015.19.1010: Articles of apparel and clothing accessories (including
gloves, mittens and mitts), for all purposes, of vulcanized
rubber other than hard rubber: Gloves, mittens and mitts:
Other: Other: Seamless, Disposable.
The Harmonized Commodity Description and Coding System Explanatory Notes
(ENs) constitute the official interpretation of the Harmonized System (HS) at the
international level. While not legally binding, the ENs provide a commentary on the
scope of each heading of the HS and are thus useful in ascertaining the proper
classification of merchandise. See T.D. 89-90, 54 Fed. Reg. 35127, 35128 (Aug. 23,
1989).
The ENs to heading 4015 state, in part, as follows:
This heading covers articles of apparel and clothing accessories (including
gloves, mittens and mitts) e.g., protective gloves and clothing for surgeons,
radiologists, divers, etc., whether assembled by means of an adhesive or by
sewing or otherwise obtained. (Emphasis added.)
There is no dispute that the merchandise is classified in heading 4015, HTSUS,
as gloves. Rather, the issue centers around whether the merchandise is classified
within 8-digit subheading 4015.19.05, HTSUS (and specifically within 10-digit statistical
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reporting number 4015.19.0550) as medical gloves or within 8-digit subheading
4015.19.10 (and specifically within 10-digit statistical reporting number 4015.19.1010)
as other than medical gloves.
Subheading 4015.19.05, HTSUS (2019) is a principal use provision pursuant to
Additional U.S. Rule of Interpretation 1(a). In E.M. Chemicals v. United States, 20 C.I.T.
382, 387; 923 F. Supp. 202, 208 (1996), the U.S. Court of International Trade
addressed principle use under Additional U.S. Rule of Interpretation 1 to the HTSUS:
The principal use of the class or kind of goods to which an import belongs is
controlling, not the principal use of the specific import. Group Italglass U.S.A.,
Inc. v. United States, 17 C.I.T. 1177, 1177, 839 F. Supp. 866, 867 (1993).
"Principal use" is defined as the use “which exceeds any other single use.”
Conversion of the Tariff Schedules of the United States Annotated Into the
Nomenclature Structure of the Harmonized System: Submitting Report at 34-35
(USITC Pub. No. 1400) (June 1983). As a result, "the fact that the merchandise
may have numerous significant uses does not prevent the Court from classifying
the merchandise according to the principal use of the class or kind to which the
merchandise belongs." Lenox Coll., 20 C.I.T. , Slip Op. 96-30 at page 4.
* * *
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.
In the instant case, the class or kind of goods that are in question are medical
gloves. And the question to be decided in the instant case is whether the goods under
consideration are a member of that class or kind of gloves that are principally used (i.e.,
use which exceeds any other single use) in a medical application.
In its submission, counsel for the protestant addresses the seven Carborundum
Factors (factors 3 and 4 are combined in a single response).
THE GENERAL PHYSICAL CHARACTERISTICS OF THE MERCHANDISE
General Physical Characteristics. The characteristics of the gloves are
consistent with the ASTM standard D6319-19 for Nitril Examination Gloves for
Medical Applications. See, Exhibit E, F and G. The physical characteristics are
also consistent with extensive FDA requirements and have been met with FDA
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pre-market approval for marketing and sale in the United States as medical gloves.
See, Exhibits D and G. Some of these models are rated specifically as
Chemotherapy gloves (Exhibits J). The subject merchandise these entries has
inspection reports which rate these gloves according to these specifications. See
Exhibits I.
The gloves under consideration are simply disposable nitrile gloves with no
apparent general physical characteristics to indicate a principal use as medical gloves.
As indicated above, they are promoted as having multiple uses (see above descriptions
and pictures from websites of entities that sell these gloves). And the record does not
establish or support with any degree of certainty use as medical gloves that exceeds
any other single use.
THE EXPECTATION OF THE ULTIMATE PURCHASERS
Expectation of the Ultimate Purchasers. The expectations of the consumers are
set by the labeling/marketing on the retail boxes which include the statements: “For
Medical Use Only” and “Examination Gloves.” See, Exhibits F and G. Consumers
expect these to be medical grade because they are marketed as such by both
SWS and its distributors. See, Exhibits F and K.
There is nothing in the record (or in the above descriptions and pictures from
websites of entities that sell these gloves) to allow one to assess with any degree of
certainty the expectations of the ultimate purchasers--particularly as the gloves are sold
to distributors and not sold directly to the ultimate purchasers.
THE CHANNELS OF TRADE IN WHICH THE MERCHANDISE MOVES & THE
ENVIRONMENT OF THE SALE (E.G. THE MANNER IN WHICH THE MERCHANDISE
IS ADVERTISED AND DISPLAYED)
Channels of Trade and Environment of Sale. We know the use, because the
gloves are sold to distributors who sell into the medical community. These
distributors will market the gloves as being for “medical” use. See, Exhibit K.
(Summary of Distributor Marketing).
There is nothing in the record (or in the above descriptions and pictures from
websites of entities that sell these gloves) to allow one to assess with any degree of
certainty the channels of trade in which the merchandise moves or the environment of
the sale (e.g., the manner in which the merchandise is advertised and displayed)--
particularly as the gloves are sold to distributors and not sold directly to the ultimate
purchasers.
THE USAGE OF THE MERCHANDISE
Usage in the Same Manner as Merchandise Which Defines the Class. These
gloves are actually used as medical examination gloves.
The gloves under consideration are disposable nitrile gloves. As indicated
above, they are promoted as having multiple uses (see above descriptions and pictures
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from websites of entities that sell these gloves). The record does not establish or
support with any degree of certainty use as medical gloves that exceeds any other
single use.
THE ECONOMIC PRACTICALITY OF SO USING THE IMPORT
Economic Practicality of Usage in the Same Manner as Merchandise Which
Defines the Class. SWS asserts that non-medical gloves are unregulated by the
FDA and are therefore much cheaper. It is economically unpractical to use medical
gloves in these unregulated categories (which the FDA has described for example
as “food service gloves” and “cleaning gloves”. See Exhibit L p. 7 of FDA Glove
Manual.
As it has not been established that the principal use of the instant gloves is as
medical gloves, one cannot assess with any degree of certainty the economic
practicality of usage of the gloves in the same manner as merchandise that defines the
class.
THE RECOGNITION IN THE TRADE OF THIS USE
Recognition in the trade of use in the manner consistent with the class.
Again, the trade (distributors) do recognize SWS gloves as within the same
class/kind as “medical gloves” because they market SWS products as “medical
gloves.” See, Exhibit F and K.
As it has not been established that the principal use of the instant gloves is as
medical gloves, one cannot assess with any degree of certainty whether the gloves
under consideration are recognized in the trade as for use as medical gloves.
Upon review of the submissions and arguments presented on behalf of the
protestant (including the above-mentioned “Supplement to Protest No. 200-21-106118”
and the arguments and materials presented during the above-mentioned November 28,
2022, virtual conference) and the above-mentioned descriptions and pictures from
websites of entities that sell the three types of gloves under consideration (i.e.,
TrueForm disposable gloves, PowerForm disposable gloves and MegaMan disposable
gloves), the record does not support or establish that the instant goods are a member of
a class or kind of gloves that are principally used (i.e., use which exceeds any other
single use) in a medical application. Thus, they cannot be classified under the HTSUS
(2019) as medical gloves.
HOLDING:
In accordance with the above analysis and by application of GRI 1, the
merchandise that is the subject of this protest (“disposable nitrile gloves”) is classified in
heading 4015, HTSUS, and by application of GRI 6 is specifically classified in 10-digit
statistical reporting number 4015.19.1010, HTSUSA (2019) which provides for: “Articles
of apparel and clothing accessories (including gloves, mittens and mitts), for all
purposes, of vulcanized rubber other than hard rubber: Gloves, mittens and mitts:
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Other: Other: Seamless, Disposable.” The 2019 column 1, general rate of duty is 3
percent ad valorem.
You are instructed to DENY the protest in full.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS (2019), products
of China classified under subheading 4015.19.10, HTSUS (2019), unless specifically
excluded, were subject to an additional 25 percent ad valorem rate of duty. At the time
of importation, the Chapter 99 subheading, i.e., 9903.88.03, should have been reported
for the products covered by this protest in addition to subheading 4015.19.10, HTSUS,
listed above.
The HTSUS is subject to periodic amendment so an importer should exercise
reasonable care in monitoring the status of goods covered by the Note cited above and
the applicable Chapter 99 subheading. For background information regarding the trade
remedy initiated pursuant to Section 301 of the Trade Act of 1974, an importer may
refer to the relevant parts of the USTR and CBP websites, which are available at
https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and
https://www.cbp.gov/trade/remedies/301-certain-products-china respectively.
Duty rates are subject to change. The text of the most recent HTSUS and the
accompanying duty rates are provided on the Internet at https://hts.usitc.gov/current.
You are instructed to notify the protestant of this decision no later than sixty days
(60) days from the date of this decision. Any reliquidation of the entry or entries in
accordance with the decision must be accomplished prior to this notification. Sixty days
from the date of the decision, the Office of Trade, Regulations and Rulings will make the
decision available to CBP personnel, and to the public on the Customs Rulings Online
Search System (“CROSS”) at https://rulings.cbp.gov/ which can be found on the U.S.
Customs and Border Protection website at http://www.cbp.gov and other methods of
public distribution.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
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