RE: Eligibility for duty-free treatment under Nairobi Protocol concerning pediatric CPAP masks from Taiwan

U.S. Department of Homeland Security U.S. Customs and Border Protection National Commodity Specialist Division One World Trade Center, Suite 51.201 New York, NY 10007 U.S. Customs and Border Protection N363757 August 18, 2026 CLA-2-90:OT:RR:NC:N3: 143 CATEGORY: Classification TARIFF NO.: 9019.20.0000; 9817.00.96 Andrea Abraham Meeks, Sheppard, Leo & Pillsbury LLP 570 Lexington Ave, 24th Floor New York, NY 10022 RE: Eligibility for duty-free treatment under Nairobi Protocol concerning pediatric CPAP masks from Taiwan Dear Ms. Abraham: In your letter dated July 27, 2026, you requested a tariff classification ruling on behalf of your client, Trinity Medical Devices, Inc. The item under consideration is specialized pediatric CPAP masks, specifically used with CPAP therapy devices. The pediatric CPAP masks come in different sizes, from Child Small, Child Medium, Child Large, Child X-Large (Item No. 11339, 11340, 11341, 1342). The CPAP Mask is intended for pediatric patients who have been prescribed Continuous Positive Airway Pressure (CPAP) therapy and is designed exclusively for use with CPAP therapy devices in home, hospital, and institutional settings. It provides a non-invasive positive airway pressure interface to support the management of chronic conditions such as Obstructive Sleep Apnea (OSA) and long-term chronic respiratory insufficiency. The mask features a durable polycarbonate frame, soft silicone cushion, and flexible silicone forehead pad to help provide a comfortable and secure fit during therapy. Additional components include a polycarbonate L-connector, silicone extension tubing, nylon fabric headgear, polycarbonate headgear buckle, and thermoplastic polyurethane ring for securing the headgear. The mask is latex-free, reusable, intended for single-patient use, and incorporates a standard ISO 5356-1/2 22 mm breathing-circuit connector. It is not intended for general respiratory use or for use with devices other than CPAP therapy devices The applicable subheading for the specialized pediatric CPAP masks will be 9019.20.0000, HTSUS, which provides for “ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof.” The general rate of duty will be free.
In your submission you also 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: “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. CBP has determined that CPAP devices designed for the treatment of obstructive sleep apnea qualify for duty-free treatment under subheading 9817.00.96, HTSUS (see NY ruling N059778, dated May 29, 2009). Furthermore, CBP has determined that component parts that are specifically designed to work exclusively with a device classifiable in subheading 9817.00.96, HTSUS, are also eligible. Accordingly, the CPAP masks (Item Nos.11339,11340, 11341, 1342) which are designed exclusively for CPAP therapy devices and used for individuals with chronic conditions such as Obstructive Sleep Apnea (OSA) and long term Chronic Respiratory Insufficiency conditions, 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 the ruling, please contact National Import Specialist Dionisia Melman at [email protected]. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division