The tariff classification, country of origin, and marking of self-adhesive silicone foam dressings from Vietnam

N354160 October 21, 2025 CLA-2-30:OT:RR:NC:N3:348 CATEGORY: Classification; Origin; Marking TARIFF NO.: 3005.10.5000; 9903.02.69 Ms. Shanshan (Shannon) Liang Liang + Mooney, PLLC 2104 Delta Way, Suite #1 Tallahassee, FL 32303 United States RE: The tariff classification, country of origin, and marking of self-adhesive silicone foam dressings from Vietnam Dear Ms. Liang: In your letter dated September 17, 2025, on behalf of your client, Winner Medical, you requested a tariff classification ruling. Your sample will be returned. The submitted sample, “self-adhesive silicone foam dressing with border,” is used to cover wounds and provides a moist healing environment. The silicone foam dressing is composed of six layers polyurethane film (top), super absorbent fiber (SAF) layer, nonwoven layer, polyurethane foam, silicone mesh layer, release film (bottom). The sample contains 10 individual packs, each dressing measures 4 inches x 4 inches (10 cm x 10 cm) and is packed for retail sale. The sample will be imported in various sizes, including 12.5 cm x 12.5 cm, 12.5 cm x 20 cm, and 18 cm x 18 cm. The applicable subheading for the subject sample will be 3005.10.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes: Adhesive dressings and other articles having an adhesive layer: Other. The rate of duty will be free. 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/. In your letter, you requested a country of origin determination for the self-adhesive silicone foam dressing with border. The manufacturing operations for this item are as follows: The polyurethane film (top), SAF layer, nonwoven layer, polyurethane foam, release film (bottom) are made in China. The silicone mesh is made in China or Germany. All six layers are shipped to Vietnam to be thermally laminated. In Vietnam, the SAF, the nonwoven and PU foam layers are uncoiled and unwound and will be thermally laminated together to create the dressing core. In Vietnam, the TPU, dressing core, silicone mesh layer, and PE release film will be unwound and laminated together. The thermal lamination will be cut to length and width, sterilized, disinfected, labeled and packaged with retail labels. When determining the country of origin for purposes of applying current trade remedies under Section 301, Section 232, and Section 201, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). For the self-adhesive silicone foam dressing with border, the raw materials from China or Germany are substantially transformed when joined together in Vietnam. When imported into the United States, the country of origin of this product is Vietnam. 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 Vietnam will be subject to an additional ad valorem rate of duty of 20 percent. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.02.69 or exclusion subheading, in addition to subheading 3005.10.5000, HTSUS, listed above. Additionally, Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States, the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940). Part 134 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP Regulations (19 CFR 134.1(b)), defines “country of origin” as the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the “country of origin” within the meaning of the marking laws and regulations. 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 Rosemarie Hayward at rosemariecasey.hayward@cbp.dhs.gov. Sincerely, (for) Evan Conceicao Designated Official Performing the Duties of the Division Director National Commodity Specialist Division