The tariff classification of sleep apnea masks from China

N351578 August 7, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9019.20.0000; 9817.00.96 Michael Perkins Rain Eight Sourcing LLC 8163 Miller Rd Hahira, GA 31632 RE: The tariff classification of sleep apnea masks from China Dear Mr. Perkins: In your letter dated July 22, 2025, you requested a tariff classification ruling. Additional information was provided via email on July 28, 2025. YF-02 Full Face Mask, YF-01 Full Face Mask, YN-03 Nasal Mask, YN-02 Nasal Mask, and YP-01 Nasal Pillow Mask are sleep apnea masks and private labeled as Rain8 AmeriFlex Comfort Series. They come in multiple sizes. They act as an interface for CPAP (continuous positive airway pressure) devices or BiPAP (bilevel positive airway pressure) devices and deliver pressurized air therapy to patients with chronic sleep apnea. The masks consist of several parts, which include the frame, cushion, elbow, swivel, and headgear. YN-03 Nasal Mask and YP-01 Nasal Pillow Mask also contain a short tube between the elbow and swivel. The frame provides support for the mask, the cushion provides the seal, the elbow is designed to provide a vent for exhaust gas and a valve to prevent asphyxiation. The headgear is used to fasten the mask to the face. The sleep apnea masks are used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system. The masks are to be used by patients (weighing>30kg) and intended for single-patient use in the hospital/institutional or home environment. The applicable subheading for all items will be 9019.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “[o]zone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof.” The general rate of duty will be free. Effective March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings 9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 20 percent ad valorem rate of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition to subheading 9019.20.0000, HTSUS, listed above. Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time products from all countries will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading 9019.20.0000, HTSUS, listed above. However, the additional duties imposed by subheadings 9903.01.24 and 9903.01.25 shall not apply to goods for which entry is properly claimed under a provision of chapter 98 of the tariff schedule pursuant to applicable regulations of U.S. Customs and Border Protection (“CBP”), and whenever CBP agrees that entry under such a provision is appropriate, except for goods entered under heading 9802.00.80; and subheadings 9802.00.40, 9802.00.50, and 9802.00.60. 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: (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. In your letter, you state that the items are used solely by individuals with chronic sleep apnea and are specifically designed for use with BiPAP and CPAP devices. The masks serve as a conduit through which the oxygen is delivered and are integral to the successful function of the devices. They are indispensable parts for the devices to assist sleep apnea impaired persons and specially designed for and marketed to them. Their use by the general public is improbable. Customs and Border Protection has determined that the 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). Online research found that BiPAP devices are used to treat sleep apnea, particularly when CPAP therapy is not sufficient or well-tolerated. CPAP machines deliver the same pressure when breathing in and breathing out. BiPAP machines provide two different pressure levels, one level of air pressure during inhalation and a lower level for exhalation. Based on the information provided and the precedent, it is our opinion that the sleep apnea masks are parts of the CPAP or bi-level systems without which the devices cannot function and thus are eligible 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