Country of origin determination for a Neurological Sponge; 19 CFR 102.21(c)(2)

N354701 October 24, 2025 OT:RR:NC:N3:351 CATEGORY: Classification, Origin TARIFF NO.: 6307.90.9891 Ms. Beth Casler Carwild Corporation / Medsorb Dominicana S.A. 3 State Pier Road New London, CT 06320 RE: Country of origin determination for a Neurological Sponge; 19 CFR 102.21(c)(2) Dear Ms. Casler: In your letter dated September 19, 2025, you requested a country of origin determination for five neuro sponges. The country of origin determination for four neurological sponges packed for retail sale will be addressed in NY N353972. This letter will address item SDP-56S, non-sterilized sponge strips imported in bulk, sterilized, and repackaged after importation. Samples were provided to this office and will be returned as per your request. The sample, item SDP-56S, described as a “Neutec Neuro,” is a single-use, disposable textile sponge designed to protect the neurological tissue and absorb blood or fluid during neurosurgery. The single layer strip shaped sponge is composed of 100 percent rayon nonwoven fabric coated on both sides with an acrylic resin. The coating is not visible to the naked eye. The sponge strip, measuring ¼ inch in width by 3 inches in length, features a 3-inch-long green barium sulfate monofilament sonically welded to the center of the fabric to facilitate X-ray detection and to help prevent the item from being left in the patient’s body. The sponge strip also features an 11 to 12-inch-long 100 percent cotton dyed blue thread sewn to the top of the sponge for ease in visibility and identification. Ten non-sterilized sponge strips are wound onto an accountability card (winding card) and placed in an unsealed glassine bag. You state that the non-sterilized sponge strips will be imported into the United States in bulk, sold and exported to a Canadian company for sterilization and final packaging. The sterilized products may remain in Canada, or enter another country’s market, or return to a U.S. warehouse and be distributed to hospitals and other healthcare facilities. You also stated that the sponge strips might have a green thread sewn to the top of the sponge for ease in visibility or identification. You state the manufacturing operations for the neurological sponge are as follows: United States: • 100 percent cotton dyed blue thread is produced and shipped in spools to Dominican Republic. • 100 percent rayon nonwoven griege fabric is produced. • The 100 percent rayon nonwoven greige fabric is coated on both sides and shipped in rolls to Dominican Republic. • The green barium sulfate monofilament strip is produced and shipped in spools to Dominican Republic. Thailand: • 100 percent polyester thread is produced and shipped in spools to Dominican Republic. Dominican Republic: • 100 percent polyester thread is braided and dyed green in the Dominican Republic. • The roll of nonwoven fabric is slit into different widths. • The green barium sulfate monofilament is sonically welded to the fabric. • The fabric is cut into different lengths of sponge strips. • The blue cotton thread or green polyester thread is sewn to the fabric. • Ten non-sterile neurological sponge strips with cotton or polyester thread are wound onto an accountability card (winding card). • Each accountability card is inspected and placed in an individual unsealed glassine bag. • 100 unsealed glassine bags are placed in a polybag, packaged in a carton, and shipped to the United States. The applicable subheading for the neuro sponge strips will be 6307.90.9891, HTSUS, which provides for “Other made up articles, including dress patterns: Other: Other: Other: Other: Other.” The rate of duty will be 7 percent ad valorem. Section 334 of the Uruguay Round Agreements Act (“URAA”) (codified at 19 U.S.C. 3592), enacted on December 8, 1994, provides the rules of origin for textiles and apparel products for purposes of the customs laws and the administration of quantitative restrictions, unless otherwise provided by the statute, entered, or withdrawn from warehouse, for consumption on or after July 1, 1996. Section 3592 has been described as Congress’s expression of substantial transformation as it relates to textile and apparel products. Section 102.21 of the Code of Federal Regulations (19 CFR 102.21), implements the URAA. The country of origin of a textile or apparel product shall be determined by the sequential application of the general rules set forth in paragraphs (c)(1) through (5) of section 102.21. See 19 CFR 102.21(c). Paragraph (c)(1) states, “The country of origin of a textile or apparel product is the single country, territory, or insular possession in which the good was wholly obtained or produced.” As the subject merchandise is not wholly obtained or produced in a single country, territory or insular possession, paragraph (c)(1) of Section 102.21 is inapplicable. Paragraph (c)(2) states, “Where the country of origin of a textile or apparel product cannot be determined under paragraph (c)(1) of this section, the country of origin of the good is the single country, territory, or insular possession in which each of the foreign materials incorporated in that good underwent an applicable change in tariff classification, and/or met any other requirement, specified for the good in paragraph (e) of this section:” Paragraph (e) in pertinent part states, The following rules shall apply for purposes of determining the country of origin of a textile or apparel product under paragraph (c)(2) of this section: HTSUS Tariff shirt and/or other requirements 6307.90 The country of origin of a good classifiable under 6307.90 is the country, territory, or insular possession in which the fabric comprising the good was formed by a fabric-making process. The “fabric-making process” is defined in 19 CFR 102.21(b)(2) as “any manufacturing operation that begins with polymers, fibers, filaments (including strips), yarns, twine, cordage, rope, or fabric strips and results in a textile fabric.” As the neuro sponge strips are comprised of fabric that is formed by a fabric-making process in a single country, that is the United States, as per the terms of tariff shift requirement country of origin is conferred in the United States. Inasmuch as the marking requirements of 19 U.S.C. 1304 are applicable only to articles of “foreign origin,” the subject neuro sponge strips are not required to be marked upon importation into the United States. Whether an article may be marked with the phrase “Made in the USA” or similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission (FTC). We suggest that you contact the FTC Division of Enforcement, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580 on the propriety of proposed markings indicating that an article is made in the U.S. This ruling 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 Kristine Dodge at kristine.dodge@cbp.dhs.gov. Sincerely, (for) Evan Conceicao Designated Official Performing the Duties of the Division Director National Commodity Specialist Division