CLA-2-84:OT:RR:NC:N1:102
Juan Moreno
Sandler, Travis and Rosenberg, PA
414 Jackson Street, Suite 200
San Francisco, CA 94111
RE: The tariff classification of a sample port valve from China
Dear Mr. Moreno:
In your letter dated August 21, 2025, you requested a tariff classification ruling, on behalf of your client,
Outset Medical Inc. Descriptive information was provided with your submission.
The product is referred to as a chlorine sample port, part number PN-0000505-F. The sample port consists of
a body that encases a pin, a bonnet and a stopper. The customized threading of the port’s body allows it to be
inserted and locked into the designated receptacle of the Tablo Hemodialysis System console’s front panel.
The console provides hemodialysis treatment for individuals with End-Stage Renal Disease (ESRD) and is
comprised of a housing equipped with various components that together remove toxins, waste and fluid from
the body. The sample port, which is primarily composed of steel material, provides a way for the user to
obtain the required water sample and determine whether the water is suitable for dialysis.
The applicable subheading for the chlorine sample port will be 8481.80.3090, Harmonized Tariff Schedule of
the United States (HTSUS), which provides for Taps, cocks, valves and similar appliances, for pipes, boiler
shells, tanks, vats or the like, including pressure-reducing valves and thermostatically controlled valves; parts
thereof: Other appliances: Hand operated: Of iron or steel: Of steel: Other. The general rate of duty will be
5.6 percent ad valorem.
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 8481.80.3090, 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 of China, Hong
Kong, and Macau will be subject to an additional ad valorem rate of duty of 10 percent. 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 8481.80.3090, HTSUS, listed above.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under
subheading 8481.80.3090, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad
valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.03,
in addition to subheading 8481.80.3090, HTSUS, listed above.
In your submission, you request consideration of a secondary classification for the article above under
9817.00.96, HTSUS, which applies to articles and parts of articles specifically designed or adapted for the
use or benefit of the permanently or chronically physically or mentally handicapped. Chapter 98, Subchapter
XVII, U.S. Note 4(a), HTSUS, defines the term blind or other physically or mentally handicapped persons as
including “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 oneself, performing manual tasks,
walking, seeing, hearing, speaking, breathing, learning, or working.”
The primary issue is whether the article is specially designed or adapted for the use or benefit of the
handicapped within the meaning of Nairobi Protocol. Although the legislative history of the Nairobi Protocol
discusses the concerns of Congress that the design, modification, or adaptation of an article must be
significant so as to clearly render the article for use by handicapped individuals, no specific definition of
these terms was established by Congress. Since it is difficult to establish a clear definition of what is
specially designed or adapted, various factors must be utilized on a case-by-case basis to determine whether a
given article is specially designed or adapted within the meaning of this statute.
In Treasury Directive 92-77, dated August 3, 1992 (Volume 26 Customs Bulletin Issue 35, dated August 26,
1992), U.S. Customs and Border Protection (CBP) set forth its position regarding certain issues arising under
the Nairobi Protocol. The first issue concerned the interpretation of the term specially designed or adapted.
CBP pointed out that a primary factor to be considered in determining whether an article was specially
designed and adapted was whether the article was easily distinguishable, by properties of the design and the
corresponding use specific to this unique design, from articles useful to non-handicapped individuals.
Therefore, if an article is solely dedicated for use by the handicapped it is CBP’s position that this would be
conclusive evidence that the article is specially designed or adapted for the handicapped for purposes of the
Nairobi Protocol.
In Headquarters Ruling Letter 556449, dated May 5, 1992, CBP set forth five factors it would consider in
determining whether an article is specially designed or adapted for the use or benefit of handicapped persons.
These factors include: (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 previously reviewed the Tablo Hemodialysis Console in New York Ruling Letter N345258, dated
February 7, 2025, and explained that by design, function, and use, the console is an article “specially
designed or adapted” for the handicapped for the purposes of subheading 9817.00.96, HTSUS. The Tablo
console is used to self-manage ESRD, which requires the removal of toxins, waste, and fluid from the body.
The issue under consideration is whether the aforementioned product is specially designed and adapted for
use in the Tablo console. Based on the information provided, the chlorine sample port features threading that
solely interfaces with the console and without its presence there would be an open orifice in the front panel of
the console. Additionally, the port allows the user to complete a sampling process required for an effective
dialysis process to occur.
Accordingly, we believe the subject product is exclusively used with the Tablo Hemodialysis System
Console and therefore, eligible for secondary classification in subheading 9817.00.96, HTSUS, which
provides for 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, free of duty
and the Merchandise Processing Fee (MPF).
Please note, the additional duties imposed by subheadings 9903.01.24, 9903.0125 and 9903.88.03 do not
apply to goods for which entry is properly claimed under a provision of chapter 98 of the HTSUS, except for
goods entered under subheading 9802.00.40, 9802.00.50, 9802.00.60 or 9802.00.80.
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 Sandra Martinez at [email protected].
Sincerely,
(for)
Denise Faingar
Acting Director
National Commodity Specialist Division