CLA-2-90:OT:RR:NC:N3:135
Tyler Keith
Flexport Customs, LLC
100 California Street
San Francisco, CA 94111
RE: The tariff classification of insulin pump patches and continuous glucose monitor patches from China
Dear Mr. Keith:
In your letter dated April 8, 2026, you requested a tariff classification ruling on behalf of your client, Skin
Grip. Additional information was provided via email dated April 28, 2026.
The products under consideration include the Tandem Mobi Pocket Patch, Medtronic Guardian/Enlite Patch,
Omnipod Patch, Libre 3+ Patch, and Dexcom G6 Patch. These are specially designed adhesive patches used
to secure insulin pumps or continuous glucose monitors (CGMs) to the skin. Such devices are widely used by
patients with chronic diabetes, a condition in which the body cannot effectively produce or utilize insulin.
The patches are tailored for specific models of CGMs and insulin pumps, ensuring firm attachment during
daily activities, including sports and outdoor activities, with reduced risk of device detachment.
Each patch is composed of a flexible fabric made from 97 percent rayon and 3 percent spandex, coated on
one side with a medical-grade adhesive consisting of 63 percent ethyl acrylate and 37 percent butyl acrylate.
The adhesive is waterproof, sweatproof, latex-free, non-cytotoxic, non-irritating, and hypoallergenic, and is
designed for wear up to 14 days. Applied in a corrugated pattern to the fabric, the adhesive promotes
breathability, allowing sweat and moisture to be absorbed and expelled, thereby enhancing comfort and
extending wear time.
The five Skin Grip adhesive patches differ primarily in size and shape, each tailored to fit a specific CGM or
insulin pump model:
Tandem Mobi Pocket Patch: Designed for Tandem Mobi insulin pumps, this patch measures
approximately 3” x 3.25”, features a built-in pocket to secure the device, and is available in black or
tan.
Medtronic Guardian/Enlite Patch: These overlay tapes secure Guardian and Enlite CGM sensors for
their 7-to-14-day wear cycle. Featuring a pre-cut design with a non-adhesive center to protect the
device, they facilitate easy application and removal, minimizing skin irritation and sensor failure.
Each patch measures approximately 3.88” x 2.38”, includes a dome-shaped center, and comes in
various colors.
Omnipod Patch: Designed for the Omnipod insulin pump, this patch measures approximately 3.88” x
3.38”, features a central cut-out to accommodate the device, and is available in multiple colors.
Libre 3+ Patch: This overlay secures the FreeStyle Libre 3 Plus CGM sensor for up to 15 days. It
offers comfort for sensitive skin, high moisture-wicking properties, and 360-degree protection during
activities such as swimming or workouts. The patch is pre-cut, thin, waterproof, and features a
non-adhesive center for easy application and removal. It measures approximately 2” x 2”, with a
dome-shaped center, and is available in various colors.
Dexcom G6 Patch: Designed for the Dexcom G6 CGM sensor, this patch ensures secure adhesion for
the full 10-day wear cycle or longer. Waterproof and sweatproof, it protects against accidental
detachment during daily activities. Made from hypoallergenic, latex-free materials, the patch is
available in clear or colorful designs for discreet or expressive use. Each patch measures
approximately 3.81” x 3.38” and features a central cut-out for the Dexcom device.
You state that, at the time of import into the United States, the five Skin Grip adhesive patch products
covered by this ruling request are in their retail packaging, ready for sale to the ultimate consumer. On the
front of each package, a product-specific sticker clearly indicates the CGM or insulin pump model for which
the patch is designed. Diabetes is a permanent or chronic condition that substantially limits one or more
major life activities. Continuous glucose monitors and insulin pumps, which may be used by individuals with
diabetes to aid in the management of their condition, must be safely, securely, and continuously attached to
the skin to function properly. The five Skin Grip adhesive patches in this ruling request are specially
designed—as evidenced by their specific sizes, shapes, and materials—to safely and securely adhere CGMs
and insulin pumps to the wearer’s skin for up to 14 days. This reduces the chance that the medical device will
detach during daily activities or participation in sports and other active pursuits, thereby helping individuals
with diabetes effectively manage their chronic condition.
You claim that all items should be classified under 9027.90.5695, Harmonized Tariff Schedule of the United
Sates (HTSUS), which provides for Instruments and apparatus for physical or chemical analysis (for
example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and
apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments
and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters);
microtomes; parts and accessories thereof: Microtomes; parts and accessories: Parts and accessories: Of
electrical instruments and apparatus: Other: Of instruments and apparatus of subheading 9027.20, 9027.30,
9027.50, 9027.81 or 9027.89: Other. We disagree for the Tandem Mobi Pocket Patch and Omnipod Patch.
These two items are specially designed for insulin pumps and will be classified elsewhere.
The applicable subheading for the Tandem Mobi Pocket Patch and Omnipod Patch will be 9021.90.8100,
HTSUS, which provides for “Orthopedic appliances, including crutches, surgical belts and trusses; splints
and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or
carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof:
Other: Other.” The rate of duty will be free.
The applicable subheading for the Medtronic Guardian/Enlite Patches, the Libre 3+ Patch, and the Dexcom
G6 Patch will be 9027.90.5695, HTSUS, which provides for “Instruments and apparatus for physical or
chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis
apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface
tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light
(including exposure meters); microtomes; parts and accessories thereof: Microtomes; parts and accessories:
Parts and accessories: Of electrical instruments and apparatus: Other: Of instruments and apparatus of
subheading 9027.20, 9027.30, 9027.50, 9027.81 or 9027.89: Other.” The general rate of duty will be free.
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: “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.
We note that in Headquarters Ruling (HQ) 561020 (dated October 14, 1998), Customs and Border Protection
(CBP) determined that individuals with diabetes suffer from a permanent or physical impairment within the
meaning of U.S. Note 4(a) to Chapter 98 of the HTSUS. Additionally, as discussed in HQ 964169 (dated
June 26, 2001), CBP stated: “People with diabetes are limited in their ability to perform a broad range of jobs
because they must be able to monitor their blood sugar, inject insulin if prescribed, and have work restrictions
due to excessive urination, possible nausea, dizziness, and fainting. This interferes with working, a major life
activity. Therefore, persons with diabetes suffer from a permanent or chronic physical impairment which
substantially limits a major life activity and are considered physically handicapped persons under U.S. Note
4(a).”
In New York Ruling N292225 (dated December 18, 2017), CBP held that Insulet’s Insulin Delivery
Omnipod qualified for secondary classification under 9817.00.96. In HQ 562869 (dated December 23, 2003),
CBP determined that an infusion set designed for use with Medtronic’s Minimed Insulin Pump for
individuals with diabetes or glucose control issues was properly classified under 9817.00.96, HTSUS. In
New York Ruling N352170 (dated August 28, 2025), CBP found that a WALG Continuous Glucose
Monitoring Patch, designed specifically to secure a CGM sensor to the skin, was eligible for secondary
classification under 9817.00.96, HTSUS.
Based on the information provided, the five Skin Grip adhesive patches are specially designed—as evidenced
by their specific sizes, shapes, and materials—to safely and securely adhere CGMs and insulin pumps to the
skin of individuals with diabetes to aid in the management of their condition. Therefore, they 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 heading 9027, please
National Import Specialist (NIS) Jason Christie at [email protected]. If you have any questions
regarding heading 9021, please contact NIS Fei Chen at [email protected].
Sincerely,
(for)
James P. Forkan
Director
National Commodity Specialist Division