The tariff classification of lancets, mobile lancets, and lancing device from an undisclosed country

N352172 August 27, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9018.39.0050; 9018.90.8000; 9817.00.96 Lisa Murrin Expeditors Tradewin LLC 795 Jubilee Drive Peabody, MA 01960 RE: The tariff classification of lancets, mobile lancets, and lancing device from an undisclosed country Dear Ms. Murrin: In your letter dated August 8, 2025, you requested a tariff classification ruling on behalf of your client, Walgreen Co. A lancet (WIC item numbers 935322, 935323, 935438, and 935439) is a needle like article encased in a plastic holder with a plastic cap. These lancets share a similar design, with variations in gauge size and the number of lancets per retail package. They are designed for use with the WALG Lancing Device (WIC 935370), which is a spring-loaded device featuring nine adjustable depth settings and an auto-ejector that holds and ejects the lancet (sold separately) into the skin to painlessly extract a drop of blood (typically from a fingertip) for blood glucose testing. The WALG Mobile Lancets 30G 25S (WIC 935321) are single use, disposable, all-in-one lancets and lancing devices. The mobile lancet features an integrated push-button mechanism, eliminating the need for additional equipment. The lancets, lancing device, and mobile lancets are intended for use by individuals with diabetes. They are marketed and sold on Walgreens’ website under the “Diabetes Management” section. The applicable subheading for the lancets (WIC item numbers 935322, 935323, 935438, and 935439) will be 9018.39.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: [s]yringes, needles, catheters, cannulae and the like; parts and accessories thereof: [o]ther: [o]ther.” The general rate of duty will be free. The applicable subheading for the Lancing Device and the WALG Mobile Lancets 30G 25S (WIC 935321) will be 9018.90.8000, HTSUS, which provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences … parts and accessories thereof: [o]ther instruments and appliances and parts and accessories thereof: [o]ther: [o]ther.” The general rate of duty will be free. In your submission you requested consideration of a secondary 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 subject lancets, lancing device, and mobile lancets are designed to be used together to obtain a diabetic’s blood sample to be analyzed by a blood glucose monitoring device. They are crucial tools for individuals with diabetes, enabling them to monitor their blood sugar levels regularly. 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 fei.chen@cbp.dhs.gov. Sincerely, (for) James Forkan Acting Director National Commodity Specialist Division