CLA-2-90:OT:RR:NC:N3:135
Lydia Pardini
Polsinelli Law Firm
1401 Eye Street N.W., Suite 800
Washington, DC 20005
RE: The tariff classification of an enteral feeding tube, an enteral syringe, and an enteral extension set from
China
Dear Mr. Pardini:
In your letter dated July 9, 2025, you requested a tariff classification ruling on behalf of Avanos Medical, Inc.
The samples were submitted, examined, and disposed of.
Three items were identified in your letter. NeoMed Enteral Feeding Tube is intended for use in neonatal and
pediatric patients to provide nutrition via nasal and oral gastric placement and is not intended for use beyond
30 days. It consists of a soft, flexible tube and an ENFit-compatible connector. The tube is specially marked
in centimeters and has a purple radiopaque stripe along the length of the tube and three feeding exit ports
(holes). You state a non-ENFit compatible connector can also be used. ENFit connectors are specially
designed to secure with an ENFit-compatible syringe, most notably the NeoMed Enteral Feeding Syringe
(described below).
NeoMed Enteral Feeding Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfer
device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or
home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all
age groups. It features an ENfit-compatible tip, which has a groove that allows it to connect to the ENFit
connector on the Enteral Feeding Tube, and has a specially fitted cap. You state the syringes are available in
a variety of volumes as small as 0.5 mL, tailored to the extremely small fluid dosing needs of premature
newborns.
NeoMed Enteral Extension Set is indicated for use in neonatal and pediatric patients as an extension set for
nasogastric or orogastric enteral feeding tubes and is available with ENFit and non-ENFit connectors. It has a
ENFit connector with a cap designed to connect an ENFit-compatible syringe, a tube with an orange stripe
along the length of the tube, a slide clamp, and another connector designed to connect to an enteral fitting
tube.
The applicable subheading for the NeoMed Enteral Feeding Syringe will be 9018.31.0080, Harmonized
Tariff Schedule of the United States (HTSUS), which provides for “[i]nstruments and appliances used in
medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical
apparatus and sight-testing instruments; parts and accessories thereof: [s]yringes, needles, catheters, cannulae
and the like; parts and accessories thereof: [s]yringes, with or without needles; parts and accessories thereof:
[s]yringes, with or without needles: [o]ther.” The general rate of duty will be free.
The applicable subheading for the NeoMed Enteral Feeding Tube will be 9018.39.0040, HTSUS, which
provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences, including
scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories
thereof: [s]yringes, needles, catheters, cannulae and the like; parts and accessories thereof: [o]ther: [b]ougies,
catheters, drains and sondes, and parts and accessories thereof: [o]ther.” The general rate of duty will be free.
The applicable subheading for the NeoMed Enteral Extension Set will be 9018.90.8000, HTSUS, which
provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences … parts
and accessories thereof: [o]ther instruments and appliances and parts and accessories thereof: [o]ther:
[o]ther.” 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 subheadings 9018.31.0080, 9018.39.0040 and 9018.90.8000, 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 subheadings
9018.31.0080, 9018.39.0040 and 9018.90.8000, HTSUS, listed above.
Pursuant to U.S. Note 31 (b) to Subchapter III, Chapter 99, HTSUS, effective September 27, 2024, products
of China classified under subheading 9018.31.0080, HTSUS, unless specifically excluded, are subject to an
additional 100 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99
subheading, i.e., 9903.91.03, in addition to subheading 9018.31.0080, HTSUS, listed above.
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 9817.0096, 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.
You state that the products described above are placed through the nasal or oral route at the Neonatal
Intensive Care Unit (“NICU”) bedside by trained neonatal clinical staff and are intended exclusively for
neonates who are unable to consume nutrition safely or effectively by mouth. You claim that the premature,
low birthweight neonates are substantially limited or impaired in the actual physical act of eating, which is a
major life activity.
On the March of Dimes’ website (See
https://www.marchofdimes.org/find-support/topics/neonatal-intensive-care-unit-nicu/common-conditions-treated-nicu
(last visited 7/29/2025), a webpage titled “Common conditions treated in the NICU” states the following:
Feeding problems are common for babies in the NICU, especially those born too early or with birth
defects. Some babies need tube feeding or IV nutrition until they can eat on their own.
Feeding problems - Not being able to breastfeed or bottle feed right away. A baby may have feeding
problems if:
They’re born before they’re able to coordinate the suck and swallow and breathe pattern.
They’re too weak or sick.
They have a birth defect (a health condition present at birth that changes the shape or function
of one or more parts of the baby’s body) that makes it hard to breastfeed or bottlefeed.
Treatment includes giving liquids and nutrients (like vitamins and minerals that help the body stay
healthy) through a tiny tube placed in a vein (a blood vessel that brings blood back to the heart) in the
baby’s hand, foot, arm, or scalp … When a baby gets food through a tube like this, it’s called
intravenous feeding.
As soon as the baby is strong enough, they’re fed breast milk or formula through a feeding tube. The
tube is placed through the nose or mouth into the baby’s stomach or intestines … The baby is fed this
way until they can breastfeed or bottlefeed.
“Enteral tube feeding is commonly used in preterm infants to provide enteral nutrition.” “Among methods of
nutrition support for preterm infants, enteral tube feeding via a nasogastric or orogastric tube is commonly
used in clinical settings.” See https://www.sciencedirect.com/science/article/abs/pii/S0020748922000177
(last visited 7/29/2025).
Requiring enteral feeding in itself doesn't automatically mean a premature baby is physically handicapped. It
often signifies temporary feeding difficulties due to prematurity or related conditions. Based on your client’s
website, the NeoMed Enteral Feeding Tube is intended for use in neonatal and pediatric patients to provide
nutrition via nasal and oral gastric placement. The NeoMed Enteral Syringe is intended to be used in clinical
or home care settings by users ranging from clinicians to laypersons in all age groups. In our opinion, the
NeoMed Enteral Feeding Tube, NeoMed Enteral Syringe, and NeoMed Enteral Extension Set are not
specially designed or adapted for the handicapped and will not qualify 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 [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division