The eligibility of lancets under the Nairobi Protocol from China

N351665 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 lancets under the Nairobi Protocol from China Dear Mr. Pfeifer: In your letter dated July 24, 2025, you requested a tariff classification ruling. iHealth Disposable Lancets (blood sampling needles) consist of metal-needle like articles having tri-bevel tips encased in plastic holders with twist-off protective caps. They are stated to be solely used by people with diabetes to penetrate the outer layer of the skin on the finger or alternate site in order to obtain a small capillary blood sample for blood glucose testing. These lancets are single-use only and must be used in conjunction with a compatible lancing device and blood glucose monitoring system. They are part of the daily self-monitoring routine for individuals with diabetes. Accurate and consistent monitoring is essential for effective diabetes treatment, maintaining overall health and preventing complications. The items are not marketed or distributed as general-purpose medical supplies. In your submission you requested consideration of a classification under 9817.00.96, HTSUS, which applies to articles and parts and accessories of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. 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 diabetic pen needles and lancets (HQ H110795, dated August 5, 2011), glucose test strips for glucose test meters (HQ H039775, dated April 17, 2009), glucose monitoring systems (NY ruling N341988, dated August 15, 2024), and carrying cases specifically designed to hold and carry blood glucose meters (HQ 563264, dated May 6, 2005), qualified for duty-free treatment under subheading 9817.00.96, HTSUS. The lancets are used to obtain a diabetic’s blood sample to be analyzed by a blood glucose monitoring device. It is a crucial tool for individuals with diabetes, enabling them to monitor their blood sugar levels regularly. Based on the precedents, the iHealth Disposable Lancets 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