CLA-2-90:OT:RR:NC:N3 135
Robert Leo
Meeks, Sheppard, Leo & Pillsbury LLP
570 Lexington Avenue, Ste 2405
New York, NY 10022
RE: The tariff classification of nasal masks and gel nasal cushions from China
Dear Mr. Leo:
In your letter dated February 24, 2025, you requested a tariff classification ruling on behalf of your client
Philips RS North America LLC. Additional information was provided by email, dated March 14, 2025.
The products under consideration are various Philips Respironics Nuance Pro Gel Nasal Pillow Masks (Part
numbers 1105167, 1105168, 1105170 through 1105172, and 1106195 [mistyped as #1106095] only differ in
size and marketplace) and Nuance Pro Gel Cushions (Part numbers 1105173, 1105174, and 1105175 only
differ in size). In the future, please limit your request to no more than five items. These masks all consist of a
headgear, a gel frame, gel cushions (pillows), and an exhalation elbow which is permanently attached to a
short tube with a swivel at the end of the tube. You indicate that the Nuance Pro Gel Nasal Pillow Masks are
used exclusively with CPAP (continuous positive airway pressure) devices and BiPAP (bilevel positive
airway pressure) devices and are intended to provide an interface for application of CPAP or bilevel therapy
to patients with chronic sleep apnea in the home or hospital/institutional environment. The Nuance Pro Gel
Cushions are also known as gel nasal pillows. They sit directly inside the nostrils and are sold as a c
omponent replacement nasal interface for the nasal pillow mask.
The applicable subheading for the Nuance Pro Gel Nasal Pillow Masks and Nuance Pro Gel Cushions 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 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.
However, the additional duties imposed by heading 9903.01.24 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. For subheadings 9802.00.40, 9802.00.50, and 9802.00.60, the additional duties apply to the
value of repairs, alterations, or processing performed (in China and Hong Kong), as described in the
applicable subheading. For heading 9802.00.80, the additional duties apply to the value of the article
assembled abroad (in China and Hong Kong), less the cost or value of such products of the United States, as
described. Products of China and Hong Kong that are provided for in heading 9903.01.24 shall continue to be
subject to antidumping, countervailing, or other duties, taxes, fees, exactions and charges that apply to such
products, as well as to the additional ad valorem rate of duty imposed by heading 9903.01.24. See U.S. Note
2 (u) to Subchapter III, Chapter 99, HTSUS.
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 9817.00.60, 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.
In your letter, you state that the masks and cushions are used solely by individuals with chronic sleep apnea
and are specifically designed for use with BiPAP and CPAP devices. The cushions are component parts of
the masks. The masks serve as a conduit through which the oxygen is delivered and are integral to the
successful function of the CPAP and BiPAP 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 previously ruled that a Blower Cap is a part of the
Trilogy EVO ventilator, which is specifically designed for individuals with profound chronic breathing
issues, and is eligible for duty-free treatment under subheading 9817.00.96, HTSUS. See NY ruling N315179
dated November 2, 2020. NY ruling N320095, dated July 12, 2021, stated the BiPAP devices ?specifically
designed? for individuals with profound chronic breathing issues are similar to Continuous Positive Airway
Pressure (CPAP) respiratory devices. The specialized Elbow w/ NIVO Port, which is a part of an AF541
mask (oro-nasal mask) and used with Respironics? BiPAP non-invasive ventilator, was eligible for duty-free
treatment under subheading 9817.00.96, HTSUS. Based on the information provided and precedent rulings, it
is our opinion that the Nuance Pro Gel Nasal Pillow Masks and Nuance Pro Gel Cushions are parts of the
respiratory devices without which the devices cannot function and thus are eligible for duty-free treatment
under subheading 9817.00.96, HTSUS.
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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division