Application for Further Review of Protest No. 2604-26-100449; Applicability of Subheading 9817.00.96, HTSUS; PureWick™ Catheters

H359928 May 20, 2026 OT:RR:CTF:VSP H359928 ACH CATEGORY: Classification TARIFF NO.: 9817.00.96 Center Director Pharmaceuticals, Health & Chemicals Center Center of Excellence and Expertise U.S. Customs and Border Protection 1100 Raymond Blvd. Newark, NJ 07102 RE: Application for Further Review of Protest No. 2604-26-100449; Applicability of Subheading 9817.00.96, HTSUS; PureWick™ Catheters Dear Center Director: This is in response to the Application for Further Review (“AFR”) of Protest No. 2604-26-100449, timely filed by counsel for CR Bard Inc. and received on March 20, 2026, contesting the denial of subheading 9817.00.96, Harmonized Tariff Schedule of the United States (HTSUS), treatment to certain PureWick™ System products. FACTS: The PureWick™ System is a noninvasive external urine management system. The System and its component parts and accessories employ external catheterization combined with low-pressure suction to continuously draw voided urine away from the body into a sealed collection canister. The PureWick™ System incorporates a discreet, portable design, including a concealed carry bag and leak-prevention features that enable patients to remain mobile and engaged in daily activities. CR Bard Inc. provided the following images of the PureWick™ catheters: 2 ISSUE: Whether the PureWick™ catheters imported by CR Bard Inc. are eligible for duty-free treatment under subheading 9817.00.96, HTSUS. LAW AND ANALYSIS: The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the duty-free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. 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.” U.S. Customs and Border Protection (“CBP”) must evaluate “for whose, if anyone’s, use and benefit is the article specially designed.” 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). In Sigvaris, the Court of International Trade (“CIT”) explained that: The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002). In Sigvaris, the court used the Plaintiff’s own advertising materials to determine whether the products were specially designed for the use of persons who are physically handicapped. 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. Thus, classification under subheading 9817.00.96, HTSUS, depends on whether the article is “specially designed or adapted for the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within any of the enumerated exclusions under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. 3 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. While the HTSUS does not establish a clear definition of “substantial limitation,” in Sigvaris, 227 F. Supp 3d at 1335, the CIT explained that “[t]he inclusion of the word ‘substantially’ denotes that the limitation must be ‘considerable in amount’ or ‘to a large degree.’” As to whether those who use catheters are handicapped, in HQ 085175, dated October 20, 1989, CBP stated, “we see no absolute correlation between being incontinent and being mentally or physically handicapped. It is quite possible to be incontinent and healthy in every other way. Incontinence in and of itself is not a physical handicap…” However, CBP determined in multiple other rulings that a person suffering from chronic incontinence is physically handicapped. See HQ 960056, dated January 30, 1997, (citing to two rulings that held certain products to be specially designed for the handicapped within subheading 9817.00.96, HTSUS); HQ 085691, dated April 18, 1990, (which considered washable, breathable diapers used by men and women in hospitals); and HQ 557529, dated March 8, 1994 (which considered an institutional adult diaper designed to manage serious, chronic incontinence problems). Further, HQ 085407, dated November 30, 1989, which uses the same language as HQ 085175 to state that there was no absolute correlation between being handicapped and incontinent, was revoked by HQ 085574, dated April 18, 1990, which held that incontinence is a physical disability that affects a person’s ability to work and granted subheading 9817.00.96, HTSUS, treatment to the articles considered in HQ 085407. CBP has also distinguished between severe, chronic incontinence and incontinence resulting in minor leakage. In HQ H328390, dated January 25, 2024; HQ H313790, dated September 29, 2022; and HQ H092545, dated April 28, 2010, CBP held that underwear that could only absorb minimal amounts of liquid was not eligible for duty-free treatment under subheading 9817.00.96, HTSUS, because the incontinence it was treating was not severe. In this case, we believe users of the PureWick™ catheters are handicapped because the catheters are designed to manage severe incontinence, not to manage minor leakage. To determine whether the PureWick™ catheters are “specially designed” for the use or benefit of a class of persons to an extent greater than for others, CBP must examine the following five factors adopted by the Court of Appeals for the Federal Circuit (“CAFC”) in Sigvaris, 899 F.3d at 1314-15: (1) physical properties of the article itself (e.g., whether the article is easily distinguishable in design, form and use from articles useful to non-handicapped persons); (2) presence of any characteristics 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) importation by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for 4 the handicapped; (4) sale in specialty stores that serve handicapped individuals; and (5) indication at the time of importation that the article is for the handicapped. See also T.D. 92-77 (26 Cust. B. 240 (1992)). There is evidence that the catheters at issue are specially designed for use by the physically handicapped. Regarding the first two Sigvaris factors, it is highly unlikely that members of the public would use these catheters unless they have significant incontinence. Further, the catheters enable those suffering from incontinence to go about their day or sleep comfortably without having to continually insert a catheter or live with a permanently implanted catheter. For the third through fifth factors, CR Bard Inc. and its parent company, Becton, Dickinson and Company (“BD”) specialize in health innovation and offer a wide variety of medical and health products, although many of the products are general medical devices and are not specifically designed for use by the handicapped.1 The PureWick™ catheters are available for sale online through the PureWick™ at home website, but are also sold online through websites like Amazon.2 Amazon does not require a prescription to purchase the PureWick™ system, but the description states that the product is “[f]or women with urinary incontinence or limited mobility who need non-invasive external urine collection.”3 Although the PureWick™ system is available to the general public, we believe it is specially designed for the handicapped because it is only marketed to and useful for those with incontinence significant enough to require continuous liquid removal, not just minimal absorption. Therefore, CBP holds that these catheters are specially designed for the use or benefit of handicapped persons. However, subheading 9817.00.96, HTSUS, excludes articles for acute or transient disability, even if those articles are specially designed for the use or benefit of handicapped persons. In HQ 556532, dated June 18, 1992, CBP held that canes were predominantly used by permanently or chronically handicapped individuals, even though individuals with acute disabilities such as sprained ankles could use them. On the other hand, CBP stated that crutches were predominantly used by individuals with acute or transient disabilities, even though they may be used by individuals with chronic or permanent disabilities. Therefore, CBP must determine whether these catheters are used predominantly by individuals with acute or transient disabilities or by individuals with chronic or permanent disabilities. 1 https://www.bd.com/en-us/products-and-solutions/products 2 https://www.purewickathome.com/ 3 https://www.amazon.com/PureWick-Urine-Collection-System-Non-Invasive/dp/B0GCHPS1HL/ref=sr_1_2?dib=eyJ2IjoiMSJ9.S-DbVuv2kppyuNXLrPY3ANvlP-1ca8vh4qhHrcY-raJpfo27CytsrrG5av8UCsx6-4Hkjr7bG_CAeXlca66UPqS-eEJYMary3Hsq9Q1SIELz7wPHUjPSc9Z9xa4mzRyjq7jiNzrwMP8ioV57X9PV0jqnXdA2kDxBc0jvh2qVfww05NLtk3wJfvhZ_0YODleGNO0U5QC7SmjjscswEKzuqBiQpza714rrmvj91Rxe0HL6or18k4y7d34JtUfeNUWOl7bJIKG7fsI2p2x6WLGsG6NR9tghekunaLhUMKvCE68.R-lLofEoDUVyOUWI06sGXrDRe07vF2QC2lb3R4QECr8&dib_tag=se&keywords=purewick&qid=1777660906&sr=8-2 5 In this case, we believe the predominant use of these catheters is for the management of chronic conditions. The systems are relatively expensive, and we believe it is unlikely those with temporary incontinence would purchase these systems due to the variety of other disposable and temporary measures that can help manage incontinence. Further, because the systems are advertised as being for home use, we do not believe they would be primarily used temporarily after surgeries in hospital settings. Therefore, we believe the PureWick™ system is used for the management of chronic incontinence. Subheading 9817.00.96, HTSUS, also excludes therapeutic and diagnostic articles. In Richards Medical Co. v. U.S., 13 C.I.T. 519 (1989), “the Court [found] that the term ‘therapeutic’ distinguishes articles, which are used to heal the condition causing a handicap, from those duty-free articles which are designed to compensate for, or adapt to, the handicapped condition.”4 The court determined that a prosthetic hip was not a therapeutic article. Further, in Travenol Lab. V. U.S., 17 C.I.T. 69 (1993), the court determined that, because kidney dialysis did not restore the kidney function of a person with renal failure, it was not a therapeutic procedure. Like the prosthetic hip and dialysis articles, the PureWick™ catheter helps manage but does not cure an underlying condition. Incontinence is an issue while individuals use the catheter and is still an issue if users stop using the catheter. Therefore, we believe the catheter do not treat, but simply help users manage the underlying incontinence. HOLDING: The PureWick™ catheters are eligible for duty-free treatment under subheading 9817.00.96, HTSUS, as articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons. Therefore, the protest should be allowed. You are instructed to notify the protestant of this decision no later than 60 days from the date of this decision. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to this notification. Sixty days from the date of the decision, the Office of Trade, Regulations and Rulings will make the decision available to CBP personnel and the public on the Customs Rulings Online Search System (“CROSS”) at https://rulings.cbp.gov/, or other methods of public distribution. Sincerely, For Yuliya A. Gulis, Director Commercial and Trade Facilitation Division 4 This case defined “therapeutic” under a predecessor heading to subheading 9817.00.96, HTSUS.