N353972 OT:RR:NC:N3:348
Beth Casler Carwild Corporation/Medsorb Dominicana S.A. 3 State Pier Road New London, CT 06320 RE: Country of origin determination for four neurological sponges; 19 CFR 102.21(c)(4); tariff shift Dear Ms. Casler: This is in reply to your letter dated September 19, 2025, requesting a country of origin determination for four neurological sponges, which will be imported into the United States. Samples were provided with your request. Item Neutec Neuro Part# SDP56S imported in bulk will be covered separately under New York Ruling N354701. All four neuro sponges are single-use, disposable surgical sponges specifically designed to protect the neurological tissue and absorb blood or fluid during neurosurgery. At the time of importation into the U.S., the subject sponges (non-sterile) are put up in individual poly pouches, where multiple pouches will be packaged in a dispenser box, for sale to hospitals exclusively. You state the surgical sponges in sealed poly pouches (without repacking) will undergo sterilization after importation into the United States. All four neuro sponges below are constructed of white nonwoven fabric of 100% rayon, not impregnated or coated with any pharmaceutical substances. They all contain a green barium sulfate monofilament strip that runs through the entire length of the pattie or strip to facilitate X-ray detection to help prevent the item from being left in the surgical area. Some of the items below have blue locating strings attached for ease in visibility and identification. Item Neutec® Neurological Pattie ¼ x ¼, Part# 35500010, contains 10 pieces of neuro patties, each measuring ¼ inch by ¼ inch with locating string wound on a counting card, packaged in a peel-back poly pouch. Item Neutec® Neurological Strip 2 x 6, Part# 35525810, contains 10 pieces of neuro strips, each measuring 2 inches by 6 inches, packaged in a peel-back poly pouch.
Item Neuro-SPG- ½ x 3, Part# 4-30-057, contains 10 pieces of neuro strips, each measuring ½ inch by 3 inches with locating string wound on a counting card, packaged in a peel-back poly pouch. Item Neuro SPG-1 x 6, Part# 4-30-302, contains 10 pieces of neuro strips, each measuring 1 inch by 6 inches, packaged in a peel-back poly pouch. The manufacturing operations for the four neuro sponges are as follows: Austria: - 100 percent rayon staple fibers are formed. United States: - Rayon fibers are needle-punched to form a nonwoven rayon griege fabric. - Nonwoven greige fabric in rolls are coated with colorless acrylic resin on both sides. Dominican Republic: - Rolls of nonwoven greige fabric are slit into different sizes. - Green Barium Sulfate monofilament is sonically welded to the nonwoven fabric throughout the entire length. - Blue locating strings are tacked onto the neuro sponges, then placed onto the winding card (for Part# 35500010 and 4-30-057 only). - Cut strips or patties are inspected, packaged in individual poly pouches and then in dispenser boxes before export to the United States. United States (After importation): - Packaged sealed poly pouches are sterilized (neuro sponges are not removed from packaging). - Sterilized products are distributed to end users (hospitals). ISSUES: What is the country of origin determination of the subject merchandise? COUNTRY OF ORIGIN - LAW AND ANALYSIS: Section 334 of the Uruguay Round Agreements Act (codified at 19 U.S.C. 3592), enacted on December 8, 1994, provided rules of origin for textiles and apparel entered, or withdrawn from warehouse for consumption, on and after July 1, 1996. Section 102.21, Customs Regulations (19 C.F.R. 102.21), published September 5, 1995 in the Federal Register, implements Section 334 (60 FR 46188). Section 334 of the URAA was amended by section 405 of the Trade and Development Act of 2000, enacted on May 18, 2000, and accordingly, section 102.21 was amended (68 Fed. Reg. 8711). Thus, 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. 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)(1) provides the rules used to determine the country of origin of a textile or apparel product under paragraph (c)(2) of this section. These rules are dependent on the classification of the good. The four neuro sponges are classified under subheading 3005.90.5090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "{W]adding, gauze, bandages and similar articles … , impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes: Other: Other: Other." 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 3005.90 If the good contains pharmaceutical substances, a change to subheading 3005.90 from any other heading; or If the goods does not contain pharmaceutical substances, a change to subheading 3005.90 from any other heading, except from heading 5007, 5111 through 5113, 5208 through 5212, 5309 through 5311, 5407 through 5408, 5512 through 5516, 5601 through 5603, 5801 through 5804, 5806, 5809, 5903, 5906 through 5907, and 6001 through 6006. The product does not contain a pharmaceutical substance and is constructed from fabric classified under heading 5603, HTS. As a result, it does not meet the terms of the tariff shift. Paragraph (c)(3) states. “Where the country of origin of a textile or apparel product cannot be determined under paragraph (c)(1) or (2) of this section: If the good was knit to shape, the country of origin of the good is the single country, territory, or insular possession in which the good was knit; or Except for fabrics of chapter 59 and goods of headings 5609, 5807, 5811, 6213, 6214, 6301 through 6306, and 6308, and subheadings 6307.10, 6307.90, 9404.90, and 9619.00.31-33 if the good was not knit to shape and the good was wholly assembled in a single country, territory, or insular possession, the country of origin of the good is the country, territory, or insular possession in which the good was wholly assembled.” The product is not knit to shape and was not wholly assembled in a single, territory or insular possession. Paragraph (c)(3) of Section 102.21 is inapplicable. Paragraph (c)(4) states, “Where the country of origin of a textile or apparel product cannot be determined under paragraph (c)(1),(2) or (3) of this section, the country of origin of the good is the single country, territory, or insular possession in which the most important assembly or manufacturing process occurred.” The manufacturing process that occurs in the Dominican Republic is considered the most important assembly or manufacturing process. HOLDING: The country of origin of the four neuro sponges is Dominican Republic pursuant to 19 CFR 102.21(c)(4).
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 [email protected].
Sincerely,
(for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division