OT:RR:NC:N3:135
Composition: LDPE plastic coated with generic adhesive. Country of Source Material: India. Country Where Manufactured: India. Details of Manufacturing Operation Performed: LDPE sheets are printed with brand name and coated with generic adhesives for enabling it to stick to the Article. 1. Foam. Foam coated with pressure sensitive adhesive attaches the Article to skin. Composition: Polyurethane foam coated with generic adhesive. Country of Source Material: EU. Country Where Manufactured: EU. Details of Manufacturing Operation Performed: High quality polystyrene foam is coated with medical grade adhesive. 1. Sensor. The Sensor is designed to serve as a female counterpart to the male Stud referenced above. The silver/silver chloride coated eyelet provides stable electrochemical interface with the skin, enabling the electrode to pick up low noise biopotential signals. Composition: Glass-filled ABS plastic substrata plated with silver/silver-chloride. Country of Source Material: USA. Country Where Manufactured: USA. Details of Manufacturing Operation Performed: The sensors are manufactured in a two-step process in the United States. First, the producer manufactures precision molded plastic eyelets. Next, it coats those eyelets with silver and silver chloride. 1. Hydrogel. Hydrogel is an amorphous gel that provides a high-water consent medium to pick up electrical signals from human skin. It is composed of multiple chemicals, including generic acrylates, sugar alcohols such as glycerin, and water. Composition: Glycerin, water, thickener. Country of Source Material: USA, various Asian countries. Country Where Manufactured: Chemicals procured from the USA and other countries are mixed in India. Details of Manufacturing Operation Performed: Certain chemicals are mixed in documented manner, which leads to a stable chemical composition which can be then converted to a cured state after exposure to UV lights. 1. Release Liner. Simple silicon coated liner enables the Article to be removed with ease from its packaging. Composition: PET plastic coated with silicone. Country of Source Material: EU, India. Country Where Manufactured: EU, India. Details of Manufacturing Operation Performed: PET sheets are coated with silicone in order to make them non-stick. You describe the assembly operation in India as follows: The assembly process begins with foam being fed into the machine, where a hole is punched to create a hydrogel well. Label stock, pre-printed with the brand’s name, is then laminated onto the foam to cover the well from one side. Next, the Stud and the Sensor are brought together and pressed through the label stock, completing their mechanical mating and establishing the conductive pathway. Hydrogel is then applied into the well directly on top of the eyelet, after which a silicone-coated release liner is placed over the hydrogel to protect it until use. Finally, the electrodes are die-cut into their finished shape, followed by quality inspection and packaging, making them ready for shipment to the United States and other countries.
When determining the country of origin, 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). In HQ ruling H300743, dated January 29, 2019, CBP held that a substantial transformation did not occur when components of a self-adhesive cutaneous electrode used for electrocardiogram and electromyogram (EMG) monitoring applications underwent “relatively simple and minor [assembly] operations involving highly repetitive, low-skill functions” in China. CBP noted that hydrogel “provide[d] the means whereby electrical activity in the body is recorded by the input circuits of an EEG/EMG machine, or electrical impulses are generated when used with stimulating equipment” and that “[t]he hydrogel’s adhesive properties are essential to allowing the product to function as a self-adhesive cutaneous electrode.” Accordingly, CBP held that the hydrogel imparted the essential character to the self-adhesive cutaneous electrode. The essence of these electrocardiograph electrodes is imparted by the hydrogel, as established by HQ ruling H300743. The assembly operations in India, which involve die-cutting the label, foam, and liner, applying a measured quantity of hydrogel under the liner, and stamping the Sensor and Stud on the two faces of the fully lined foam, are relatively simple and do not constitute a substantial transformation. India is the country where the simple assembly operations take place to produce the final product and where the hydrogel is manufactured. As stated above, the hydrogel is the essence of the electrodes. Therefore, for marking and duty assessment purposes, we find that the country of origin for the imported electrocardiograph electrodes is India. This determination aligns with our previous findings for almost identical electrocardiograph electrodes in NY ruling N318544, dated April 15, 2021. 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 [email protected].
Sincerely,
(for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division