The tariff classification of insulin pump patches and continuous glucose monitor patches from China
Active· CBP ruling HQ N360516· Issued 2026-04-29
Ruling text
N360516 April 29, 2026 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9021.90.8100; 9027.90.5695; 9817.00.96 Tyler Keith Flexport Customs, LLC 100 California Street San Francisco, CA 94111 RE: The tariff classification of insulin pump patches and continuous glucose monitor patches from China Dear Mr. Keith: In your letter dated April 8, 2026, you requested a tariff classification ruling on behalf of your client, Skin Grip. Additional information was provided via email dated April 28, 2026. The products under consideration include the Tandem Mobi Pocket Patch, Medtronic Guardian/Enlite Patch, Omnipod Patch, Libre 3+ Patch, and Dexcom G6 Patch. These are specially designed adhesive patches used to secure insulin pumps or continuous glucose monitors (CGMs) to the skin. Such devices are widely used by patients with chronic diabetes, a condition in which the body cannot effectively produce or utilize insulin. The patches are tailored for specific models of CGMs and insulin pumps, ensuring firm attachment during daily activities, including sports and outdoor activities, with reduced risk of device detachment. Each patch is composed of a flexible fabric made from 97 percent rayon and 3 percent spandex, coated on one side with a medical-grade adhesive consisting of 63 percent ethyl acrylate and 37 percent butyl acrylate. The adhesive is waterproof, sweatproof, latex-free, non-cytotoxic, non-irritating, and hypoallergenic, and is designed for wear up to 14 days. Applied in a corrugated pattern to the fabric, the adhesive promotes breathability, allowing sweat and moisture to be absorbed and expelled, thereby enhancing comfort and extending wear time. The five Skin Grip adhesive patches differ primarily in size and shape, each tailored to fit a specific CGM or insulin pump model: Tandem Mobi Pocket Patch: Designed for Tandem Mobi insulin pumps, this patch measures approximately 3” x 3.25”, features a built-in pocket to secure the device, and is available in black or tan. Medtronic Guardian/Enlite Patch: These overlay tapes secure Guardian and Enlite CGM sensors for their 7-to-14-day wear cycle. Featuring a pre-cut design with a non-adhesive center to protect the device, they facilitate easy application and removal, minimizing skin irritation and sensor failure. Each patch measures approximately 3.88” x 2.38”, includes a dome-shaped center, and comes in various colors. Omnipod Patch: Designed for the Omnipod insulin pump, this patch measures approximately 3.88” x 3.38”, features a central cut-out to accommodate the device, and is available in multiple colors. Libre 3+ Patch: This overlay secures the FreeStyle Libre 3 Plus CGM sensor for up to 15 days. It offers comfort for sensitive skin, high moisture-wicking properties, and 360-degree protection during activities such as swimming or workouts. The patch is pre-cut, thin, waterproof, and features a non-adhesive center for easy application and removal. It measures approximately 2” x 2”, with a dome-shaped center, and is available in various colors. Dexcom G6 Patch: Designed for the Dexcom G6 CGM sensor, this patch ensures secure adhesion for the full 10-day wear cycle or longer. Waterproof and sweatproof, it protects against accidental detachment during daily activities. Made from hypoallergenic, latex-free materials, the patch is available in clear or colorful designs for discreet or expressive use. Each patch measures approximately 3.81” x 3.38” and features a central cut-out for the Dexcom device. You state that, at the time of import into the United States, the five Skin Grip adhesive patch products covered by this ruling request are in their retail packaging, ready for sale to the ultimate consumer. On the front of each package, a product-specific sticker clearly indicates the CGM or insulin pump model for which the patch is designed. Diabetes is a permanent or chronic condition that substantially limits one or more major life activities. Continuous glucose monitors and insulin pumps, which may be used by individuals with diabetes to aid in the management of their condition, must be safely, securely, and continuously attached to the skin to function properly. The five Skin Grip adhesive patches in this ruling request are specially designed—as evidenced by their specific sizes, shapes, and materials—to safely and securely adhere CGMs and insulin pumps to the wearer’s skin for up to 14 days. This reduces the chance that the medical device will detach during daily activities or participation in sports and other active pursuits, thereby helping individuals with diabetes effectively manage their chronic condition. You claim that all items should be classified under 9027.90.5695, Harmonized Tariff Schedule of the United Sates (HTSUS), which provides for Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Microtomes; parts and accessories: Parts and accessories: Of electrical instruments and apparatus: Other: Of instruments and apparatus of subheading 9027.20, 9027.30, 9027.50, 9027.81 or 9027.89: Other. We disagree for the Tandem Mobi Pocket Patch and Omnipod Patch. These two items are specially designed for insulin pumps and will be classified elsewhere. The applicable subheading for the Tandem Mobi Pocket Patch and Omnipod Patch will be 9021.90.8100, HTSUS, which provides for “Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof: Other: Other.” The rate of duty will be free. The applicable subheading for the Medtronic Guardian/Enlite Patches, the Libre 3+ Patch, and the Dexcom G6 Patch will be 9027.90.5695, HTSUS, which provides for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Microtomes; parts and accessories: Parts and accessories: Of electrical instruments and apparatus: Other: Of instruments and apparatus of subheading 9027.20, 9027.30, 9027.50, 9027.81 or 9027.89: Other.” 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: “Articles 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 . . . Other.” 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 in Headquarters Ruling (HQ) 561020 (dated October 14, 1998), Customs and Border Protection (CBP) determined that individuals with diabetes suffer from a permanent or physical impairment within the meaning of U.S. Note 4(a) to Chapter 98 of the HTSUS. Additionally, as discussed in HQ 964169 (dated June 26, 2001), CBP stated: “People with diabetes are limited in their ability to perform a broad range of jobs because they must be able to monitor their blood sugar, inject insulin if prescribed, and have work restrictions due to excessive urination, possible nausea, dizziness, and fainting. This interferes with working, a major life activity. Therefore, persons with diabetes suffer from a permanent or chronic physical impairment which substantially limits a major life activity and are considered physically handicapped persons under U.S. Note 4(a).” In New York Ruling N292225 (dated December 18, 2017), CBP held that Insulet’s Insulin Delivery Omnipod qualified for secondary classification under 9817.00.96. In HQ 562869 (dated December 23, 2003), CBP determined that an infusion set designed for use with Medtronic’s Minimed Insulin Pump for individuals with diabetes or glucose control issues was properly classified under 9817.00.96, HTSUS. In New York Ruling N352170 (dated August 28, 2025), CBP found that a WALG Continuous Glucose Monitoring Patch, designed specifically to secure a CGM sensor to the skin, was eligible for secondary classification under 9817.00.96, HTSUS. Based on the information provided, the five Skin Grip adhesive patches are specially designed—as evidenced by their specific sizes, shapes, and materials—to safely and securely adhere CGMs and insulin pumps to the skin of individuals with diabetes to aid in the management of their condition. Therefore, they qualify for duty-free treatment under subheading 9817.00.96, HTSUS. The 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/. This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated Cargo Systems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies. 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 heading 9027, please National Import Specialist (NIS) Jason Christie at jason.m.christie@cbp.dhs.gov. If you have any questions regarding heading 9021, please contact NIS Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division
Source: rulings.cbp.gov — ruling N360516, retrieved 2026-10-12T06:05:35Z, republished verbatim. This digest is informational; only CBP issues binding rulings.