The country of origin of an electrosurgical patient return electrode

N356150 December 5, 2025 OT:RR:NC::N3:135 CATEGORY: Origin Jaipat Jain Lazare Potter Glazer & Moyle LLP 747 3rd Ave, New York New York, NY 10017 RE: The country of origin of an electrosurgical patient return electrode Dear Mr. Jain: In your letter dated November 17, 2025, on behalf of your client, Medico Electrodes International Limited, you requested a country of origin ruling on an electrosurgical patient return electrode (also called electrosurgical dispersive electrode, electrosurgical neutral electrode, patient return electrode, or a grounding pad). The submitted samples have been reviewed and will be disposed of. In your submission, you describe a scenario where an electrosurgical patient return electrode (the “Article”) is assembled in India from five components, all of which are manufactured and sourced from various countries. An electrosurgical patient return electrode is a single-use, non-sterile, disposable component used with electrosurgical generators during surgery. Electrosurgery is a surgical technique that uses high-frequency electrical currents to cut, remove, or destroy tissue and to control bleeding during various medical procedures. The Article’s function is to safely return high-frequency current from the patient’s body back to the generator, dispersing it over a large contact area to prevent burns or tissue injury. The electrode consists of five distinct layers of materials. These are (1) a release liner (also called mylar or protective cover), (2) hydrogel (conductive gel), (3) dielectric ink (some versions may not include this), (4) aluminum foil backed with a polyethylene foam pad, (5) an adhesive carrier (adhesive on a foam roll). The aluminum foil and the hydrogel are the conductive layers. The component parts used to produce the finished Article in India are described, in part, as follows: Release Liner. The release liner is a polyester film coated with silicone that protects the hydrogel surface until use, ensuring the pad remains sterile and easy to handle. In terms of composition, it is made of PET coated with silicone. Composition: PET plastic coated with silicone. Country of Source Material: EU. Country Where Manufactured: Italy. Details of Manufacturing Operation Performed: PET sheets are coated with silicone in order to make the sheets non-sticking. Hydrogel. The hydrogel is a polymerized, water-rich conductive gel that adheres the pad securely to the patient’s skin and provides a low-impedance interface essential for safe current return during surgery. In terms of composition, it's made of glycerin, water, thickener, polymers and conductivity enhancement chemicals. It is one of the critical components of the electrode. Composition: Glycerin, water, thickener, polymers and conductivity enhancement chemicals. Country of Source Material: UK County Where Manufactured: UK Details of Manufacturing Operation: The ingredients are mixed in documented manner in accordance with proprietary formula in specialized equipment leading to a ultra-low impedance formulation that is stable when cured state after exposure to UV lights. Dielectric Ink. The dielectric ink is not used in all models of electrosurgical electrodes. Its main purpose is to enhance the performance of current distribution. In terms of composition, it is dielectric particles suspended in an ink. Composition: Dielectric particles suspended in ink. Country of Sourced Material: USA. Country Where Manufactured: USA. Details of Manufacturing Operation Performed: Dielectric non-conducting particle are suspended in a polymer binder ink. When polarized in and electric field, the particles do not allow electric current to flow but can store electrical energy by aligning its internal charges. Aluminum Foil. The aluminum foil is a thin conductive sheet that disperses high-frequency surgical current evenly across the contact area, preventing hotspots and reducing the risk of burns. Its composition is medical grade aluminum with a PET backing. Composition: Medical grade aluminum with PET backing. Country of Source Material: UK. Country Where Manufactured: UK. Details of Manufacturing Operation Performed: Aluminum foils are laminated with a thin layer of PET in order to make the foil resilient and mechanically stable. The foil is washed clean so as to enable it to better stick with hydrogel. Adhesive Carrier. The adhesive carrier is a foam or nonwoven backing that provides mechanical stability, supports the foil and hydrogel layers, and allows the electrode to conform to the patient’s body throughout the procedure. In terms of composition, it is made of foam or no-woven laminate coated with a medicinal generic pressure sensitive adhesive. Composition: A foam or non-woven laminate coated with a medical generic pressure sensitive adhesive. Country of Source Material: EU. Country Where Manufactured: France. Details of Manufacturing Operation Performed: Commercial non-woven foam is coated with pressure sensitive adhesive using coating machines. You describe the assembly in India as follows: The assembly of the Article is carried out on standardized rotary die-cutting and laminating equipment. The aluminum foil coated with hydrogel is first unwound from roll form and fed into the laminating line. A release liner is then applied directly over the hydrogel surface to protect it prior to use. This intermediate structure is passed further downstream, where the first cutting tool shapes the material against the liner. Following this, an adhesive carrier —such as foam or nonwoven cloth, pre-coated with a generic pressure sensitive adhesive — is laminated on top to provide bulk, handling strength, and patient adhesion support. Finally, a second die-cutting station trims the pad into its final format while the waste matrix is stripped away, leaving the finished electrosurgical pads on a release liner ready for packaging. After the machines assemble the finished product, a sorter visually inspects it at the end of line for possible cosmetic defects. Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States, the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940). Part 134 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP Regulations (19 CFR 134.1(b)), defines “country of origin” as the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the “country of origin” within the meaning of the marking laws and regulations. A substantial transformation occurs when, as a result of manufacturing process, a new and different article emerges, having a distinct name, character or use, which is different from that originally possessed by the article or material before being subjected to the manufacturing process. See United States v. Gibson-Thomsen Co., Inc., 27 C.C.P.A. 267 (C.A.D. 98) (1940) and 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 this case, the assembly operation is limited to die cutting and the sequential layering of the five components by automated machines. The process is relatively simple and does not constitute a substantial transformation. None of the foreign components undergo a change in name, use or character in India. The function of the electrosurgical patient return electrode is to safely return high-frequency current from the patient’s body back to the generator, dispersing it over the large contact area of the grounding pad in order to prevent burns or tissue injury. That function is performed by two components – the specifically formulated hydrogel and the laminated aluminum foil. In addition, both components account for more than 50 percent of the product’s cost. In our opinion, the essence of the product is imparted by the hydrogel and aluminum foil, which are manufactured in the United Kingdom. Accordingly, the country of origin for the electrosurgical patient return electrode is the United Kingdom for duties and marking purposes. Section 134.46, CBP Regulations (19 CFR 134.46) requires the name of the country of origin preceded by “Made in,” “Product of”, or other words of similar meaning to be in close proximity and in at least a comparable size to the name of any city or locality appearing on the article which is not the country of origin of the article. Customs has ruled that in order to satisfy the close proximity requirement, the country of origin marking must generally appear on the same side(s) or surface(s) in which the name of the geographical reference other than the country of origin appears. Two samples were provided for review. The top front of the sample pouch displays the brand name, the manufacturer name, and the product name with the latter printed in multiple languages. The bottom front provides the full manufacturer's name, a print of “An ISO 13485 company”, the website, and an Indian address (“…, India”). On the upper portion of the pouch back, an electrode diagram and five images illustrating use steps are present. The bottom of the pouch back lists the manufacture license number, various symbols (e.g. Rx Only, non-sterile), “Medico Electrodes Ltd”, a Belgian company address (“…, Belgium”) and “Made In India.” Based on the foregoing, the pouch must be marked “Made in the United Kingdom” (or similar wording), placed in close proximity to and in at least a comparable size to any Indian or Belgian locality or country names appearing on the front or back of the pouch. 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) Deborah Marinucci Designated Official Performing the Duties of the Division Director National Commodity Specialist Division