The country of origin of an IV administration set, an IV extension set and a tube transfer set

N348081 May 7, 2025 OT:RR:NC:N3:135 CATEGORY: Origin Zhi Hong Zhou BQ Plus Medical Co. Ltd No 18 Cheye Rd Chedun Town Songjiang District Shanghai 201611 China RE: The country of origin of an IV administration set, an IV extension set and a tube transfer set Dear Mr. Zhou: In your letter dated April 22, 2025, you requested a country of origin ruling on behalf of Medline Industries, LP. The products under consideration are an IV administration set, an IV extension set and a tube transfer set. The IV administration set is composed of a drip chamber, a roller clamp, a slide clamp, a Y injection site, a male luer lock, primary PVC tubing, and secondary PVC tubing. It is intended to deliver fluids or medications intravenously. The IV administration 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 patients catheter. The IV extension set is composed of a female luer lock, a male Luer lock, a slide clamp, and PVC tubing. It is intended to connect between the primary IV administration and the patient, allowing for more flexible line management. The tube transfer set is composed of male luer locks, silicone tubing, PVC tubing, a slide clamp, and pump connectors. The transfer set is used in sterile compounding pharmacies or cleanrooms to move IV fluids or drugs between reservoirs (e.g., IV bags, vials syringes) using peristaltic pumps. The assembly process for each product is described in your letter as follows: IV Administration set assembly process: In a Chinese certified cleanroom, medical grade Korean primary PVC tubing (2000mm/78.7 inches) and Korean secondary PVC tubing(300mm/11.8 inches) are bonded with the Chinese drip chamber, Y-site, and luer connector using cyclohexanone solvent. Next the Chinese roller and slide clamps are added to the main tubing. Lastly, the product is leak tested, packaged and ethylene oxide (EO) sterilized. IV Extension Set assembly process: In China, the Korean PVC tubing is cut to 60 inches and assembled with the Chinese male and female luer connectors using cyclohexanone solvent bonding. A Chinese origin clamp is installed then all components are visually inspected, leak tested, packaged, and EO sterilized. Tube Transfer Set assembly process: In a Chinese certified cleanroom the approx. 20000 mm/78.7 inches Korean PVC tube and 150mm Chinese silicone tube are inspected and cut. The silicone tubing is connected to two Chinese pump connectors and the PVC tubing is connected to the silicone tubing on one side and two Chinese male luer locks on the other using cyclohexanone solvent bonding. Next the China origin side clamp is placed on the PVC segment. Then all components are leak tested, inspected, 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). In the case of the IV Administration Set, the assembly occurring in China is a minor process. Specifically, the processes of bonding and joining of China origin components to the Korean origin primary and secondary PVC tubing do not change the name, character and use of the pre-cut tubing. We find no substantial transformation occurs in China. We also note that sterilization in China does not substantially transform the IV Administration Set. See HQ ruling 561167, dated Dec. 14, 1998. Accordingly, the country of origin of the IV Administration Set will be Korea. The assembly process is similar in the case of the IV Extension Set, except you state the Korea origin PVC tubing is cut in China to 60 inches before assembling 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. The processes of cutting, bonding, and joining of China origin components to the Korean origin PVC tubing do not change the name, character and use of the PVC tubing. We find no substantial transformation occurs in China. We also note that sterilization in China does not substantially transform the IV Extension Set. See HQ ruling 561167, dated Dec. 14, 1998. Accordingly, the country of origin of the IV Extension Set will be Korea. Similar to the IV Extension Set, in the Tube Transfer Set, the Korea origin PVC tube (2000mm) is cut in China and inspected along with the shorter Chinese silicon tubing. After the attachment of Chinese components on the silicon tubing, both tubes are connected and other components are attached. Based on the above, in our opinion, the processes of cutting, bonding and joining of China origin components and short tubing to the longer Korean origin PVC tubing do not change the name, character and use of the Korean tubing. We find no substantial transformation occurred in China. We also note that sterilization in China does not substantially transform the Tube Transfer Set. See HQ ruling 561167, dated Dec. 14, 1998. You explained that the silicone segment, although important for the pump’s compatibility, is short and secondary in function. Accordingly, the country of origin of the Tube Transfer Set will be 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, Steven A. Mack Director National Commodity Specialist Division