The eligibility of blood glucose test strips under the Nairobi Protocol from China

N351664 August 4, 2025 CLA-2-98:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9817.00.96 Matthew Pfeifer iHealth Labs 880 W Maude Ave Sunnyvale, CA 94085 RE: The eligibility of blood glucose test strips under the Nairobi Protocol from China Dear Mr. Pfeifer: In your letter dated July 24, 2025, you requested a tariff classification ruling. EGS-2003 Blood Glucose Test Strips are designed for use with Blood Glucose Monitoring Systems to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips, palm, forearm, upper arm, calf, or thigh. They are single-patient use and designed solely for use by persons with diabetes to monitor their blood glucose levels. The glucose measurement is based on an electrochemical reaction between glucose in the blood and the reagent on the strip, generating an electrical current that the glucose meter converts to a blood glucose reading. In your submission you requested consideration of a 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 9817.00.96, 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, the EGS-2003 Blood Glucose Test Strips 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 fei.chen@cbp.dhs.gov. Sincerely, (for) James Forkan Acting Director National Commodity Specialist Division