CLA-2-38:OT:RR:NC:N3:135
Samuel Finkelstein
LMD Trade Law PLLC
1629 K Street NW, Suite 300
Washington, DC 20006
RE: The tariff classification of blood glucose test strips from South Korea
Dear Mr. Finkelstein:
In your letter dated July 14, 2025, you requested a tariff classification ruling on behalf of your client, i-SENS
USA, Inc.
The items in consideration are CareSens N Blood Glucose Test Strips (Part # 164104-205) and two other
types of Blood Glucose Test Strips (Part # TE-BBGS-A1 and Part # 343105). They are made of different
layers and one layer contains a chemical mixture (a reagent). They are designed solely for use by persons
with diabetes to monitor their blood glucose levels. The blood glucose test strip is designed to be inserted into
a blood glucose meter. The user applies a small sample of blood obtained using a lancing device to the test
strip. Glucose in the blood sample reacts with the chemical mixture on the test strip. This yields a small
electrical current. The blood glucose meter measures this current. It then shows the blood glucose result
proportional to the current.
Based on the complete chemical breakdown of the above blood glucose test strips, the chemical mixtures do
not contain antigens or antisera. The applicable subheading for the blood glucose test strips will be
3822.19.0080, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “[d]iagnostic
or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing,
whether or not put up in the form of kits, other than those of heading 3006; certified reference materials:
[d]iagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on
a backing, whether or not put up in the form of kits: [o]ther: [o]ther: [o]ther.” The general rate of duty will be
free.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must
be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the
Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time products from all countries
will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the
Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading
3822.19.0080 HTSUS, listed above.
However, the additional duties imposed by subheading 9903.01.25 shall not apply to goods for which entry is
properly claimed under a provision of chapter 98 of the tariff schedule pursuant to applicable regulations of
U.S. Customs and Border Protection (“CBP”), and whenever CBP agrees that entry under such a provision is
appropriate, except for goods entered under heading 9802.00.80; and subheadings 9802.00.40, 9802.00.50,
and 9802.00.60.
In your submission you requested consideration of a secondary classification under subheading 9817.00.96,
HTSUS, which covers: “[a]rticles specially designed or adapted for the use or benefit of the blind or other
physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and
artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: [o]ther.”
Subheading 9817.00.96, HTSUS, covers: “[a]rticles specially designed or adapted for the use or benefit of the
blind or other physically or mentally handicapped persons; parts and accessories (except parts and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the
foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes
“any person suffering from a permanent or chronic physical or mental impairment which substantially limits
one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS.
Subheading 9817.00.60, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308
(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent
greater than in other cases or towards others” and “designed” means something that is “done, performed, or
made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We
must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,
whether “those persons [are] physically handicapped .” Sigvaris, 899 F.3d at 1314. The Court of Appeals for
the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the
merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than
for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection
(CBP):
(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by
properties of the design, form, and the corresponding use specific to this unique design, from articles
useful to non-handicapped persons); (2) whether any characteristics are present that create a
substantial probability of use by the chronically handicapped so that the article is easily
distinguishable from articles useful to the general public and any use thereof by the general public is
so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or
distributors recognized or proven to be involved in this class or kind of articles for the handicapped;
(4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5)
whether the condition of the articles at the time of importation indicates that these articles are for the
handicapped.
We note that CBP has consistently ruled that persons with diabetes are considered physically handicapped
within the meaning of U.S. Note 4(a). See e.g., HQ 964169, dated June 26, 2001, HQ 561283, dated August
26, 1999, and HQ 561020, dated October 14, 1998. CBP has previously ruled that the glucose test strips for
glucose test meters (HQ H039775, dated April 17, 2009, and HQ 562887, dated January 7, 2004) qualified
for duty-free treatment under subheading 9817.00.96, HTSUS. The instant blood glucose test strips are
specially designed for the use or benefit of people with diabetes, enabling them to monitor their blood sugar
levels regularly when used with the blood glucose meters. Based on the precedents, they qualify for duty-free
treatment under subheading 9817.00.96, HTSUS.
The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided
for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying
duty rates are provided at https://hts.usitc.gov/.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Fei Chen at [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division