The country of origin of an IV administration set and an IV extension set

N355059 November 6, 2025 OT:RR:NC:N3:135 CATEGORY: Origin Zhi Hong Zhou BQ Plus Medical Co. Ltd No 18 Cheye Rd Chedun Town Songjiang District China RE: The country of origin of an IV administration set and an IV extension set Dear Mr. Zhou: In your letter dated April 22, 2025, you requested a country of origin ruling for three medical products on behalf of Codan US Corporation. Additional information was provided by email dated October 22, 2025. One of the products, the transfusion set, will be addressed under a separate correspondence. The IV administration set is composed of a drip chamber, a back check valve, two needle free valves, a roller clam, a slide clamp, a male luer lock and primary PVC tubing (approximately 98”). It is intended to deliver fluids or medications intravenously from an IV bag to the patient. The set connects to an IV fluid bag via the drip chamber and allows for manual flow control using clamps. The Y-site enables injection of additional medications, and the male luer lock ensures secure connection to the patient's catheter. You assert that the primary functional component is the PVC tubing from South Korea, forming the main fluid path. It accounts for approximately 74 percent of material cost and 61 percent of total cost. IV Administration set assembly process in China: In a Chinese certified cleanroom, medical grade South Korean primary PVC tubing (2500mm/98.4 inches) is bonded with the Chinese drip chamber, back check valve, luer connector, and Polish or Chinese needle-free valve using cyclohexane solvent. Next, the Chinese roller and slide clamps are added to the tubing. Lastly, the product is leak tested, packaged and ethylene oxide (EO) sterilized. The IV extension set is designed to extend the reach of primary IV sets and improve patient mobility. It is composed of a female luer lock, a male luer lock, a slide clamp, and PVC tubing (approximately 60”). The set is intended to connect between the primary IV administration set and the patient, allowing for more flexible line management. You claim that the PVC tubing is the primary component providing the functional channel for fluid transfer. It accounts for approximately 87 percent of material cost and 62 percent of total cost. IV Extension Set assembly process in China: In China, the South Korean PVC tubing is cut to 60 inches and assembled with the Chinese male and female luer connectors using cyclohexanone solvent bonding. A Chinese side clamp is installed; then all components are visually inspected, leak tested, packaged, and EO sterilized. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter 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 IV Administration Set, the assembly process in China is considered minor. The bonding and joining of China-origin components to the South Korean PVC tubing do not change the name, character, or use of the pre-cut tubing. We find no substantial transformation occurs in China. Furthermore, sterilization in China also does not substantially transform the IV Administration Set. See HQ ruling 561167, dated Dec. 14, 1998. You explain that the PVC tubing is the primary functional component forming the main fluid path and is the most expensive component. It constitutes the essence of the set. Accordingly, the country of origin of the IV Administration Set will be South Korea. The assembly process for the IV Extension Set is similar, with the distinction that the Korea-origin PVC tubing is cut to 60 inches in China before assembly with Chinese components. In HQ ruling 734720, dated 10/22/92, CBP determined that cutting U.S.-manufactured self-adhesive tape to length and width in Canada did not substantially transform the tape into a product of Canada. Also see HQ 729316, dated April 20, 1989. Similarly, the processes of cutting, bonding, and joining China-origin components to the South Korean-origin PVC tubing do not change the name, character and use of the PVC tubing. We find no substantial transformation occurs in China. Furthermore, sterilization in China does not substantially transform the IV Extension Set. See HQ ruling 561167, dated Dec. 14, 1998. You explain that the PVC tubing is the primary component providing the functional channel for fluid transfer and is the most expensive component. It constitutes the essence of the set. Accordingly, the country of origin of the IV Extension Set will be South Korea. 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 Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) Evan Conceicao Designated Official Performing the Duties of the Division Director National Commodity Specialist Division