The country of origin of blood lancets

N353976
October 14, 2025
OT:RR:NC:N3:135
CATEGORY: Origin Lawrence R. Pilon Rock Trade Law LLC 134 N LaSalle Street Chicago, IL 60602 RE: The country of origin of blood lancets Dear Mr. Pilon: In your letter dated September 19, 2025, you requested a country of origin ruling on blood lancets on behalf of SteriLance Medical (Suzhou) Inc. The products under consideration are disposable single-use blood lancets. They are medical devices used to prick a patient’s skin (typically the patient’s finger) in order to draw a droplet of capillary blood for sampling. They are principally used for in-home or clinical diabetic blood glucose monitoring. Each lancet consists essentially of a sharpened solid steel needle with a tri-beveled tip in gauges ranging from 33G – 21G (0.20mm – 0.81mm nominal outside diameter). The sharpened needle is embedded in an injection molded plastic grip (plastic housing). The molded plastic grip is shaped to create a twist-off cap that, when twisted off, exposes the sharpened tip of the steel needle, which is then used to prick the patient’s skin, drawing a droplet of blood for testing. After a single use each lancet is safely disposed of. The sharpened solid steel needle performs the lancet’s sole medical function, puncturing the skin to release a droplet of the patient’s capillary blood. The needle is fully functional on its own and capable of carrying out its intended clinical purpose without reliance on the surrounding plastic grip. The plastic grip serves solely to facilitate safe and convenient storage, handling, use, and disposal of the lancet needle. The grip has no independent medical function and cannot puncture the skin or release blood. The lancets are a single-use item, principally sold packaged in boxes of 50, 100, or 200 units. The manufacturing process is described as follows: In Slovakia, the sharpened solid steel needles are fully manufactured. Manufacturing operations begin with lengths of solid stainless surgical steel wire in outside diameters ranging between 33- 21 gauge (approx. 0.20 – 0.81mm). Using specialized machinery, the steel wire is first straightened and cut to precise length. The tip of each cut length is then ground in multiple grinding operations to its final sharpened and faceted point, resulting in a finished, fully functional and sterilizable solid lancet needle, again using specialized machinery for this purpose. At this point the lancet needles are no longer usable for any purpose other than as lancet needles. The finished lancet needles are then packaged and shipped in bulk to China for final processing.

In China, the finished lancet needles undergo a visual inspection, but no additional mechanical or functional processing is performed on the needles. The steel lancet needles are loaded into an integrated automatic injection molding machine, where the plastic grip surface is injection molded around each finished lancet needle, using locally sourced plastic resin. Finally, the disposable blood lancets are inspected, gamma-sterilized, and packaged into their retail packaging formats, generally as boxes of 50, 100, or 200 units for shipment to the United States. The cost of the steel lancet needle itself varies slightly depending on the gauge of the lancet needle (larger needles generally costing more than smaller gauges) but regardless of the needle gauge, in every case the cost of the steel lancet needle alone dominates the value of the finished lancet, whether viewed based on the cost of materials, the total manufacturing cost, or the resulting total packaged and sterilized cost. When determining the country of origin for purposes of applying ordinary most favored nation duties, current trade remedies under Section 301, and additional duties, 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). Additionally, 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. In this case, the addition of a plastic grip to the lancet needles via injection molding along with gamma sterilizing and packaging in China are deemed simple and minor operations. These processes do not change the name, character, and use of the sharp, tri-beveled needles. Therefore, we find that no substantial transformation occurs in China, and the sharp, tri-beveled needles remain the essence of the blood lancets. Accordingly, the country of origin for the blood lancets will be Slovakia for marking and duty purposes. 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