The country of origin of disposable hubbed hypodermic needles

N361712June 1, 2026OT:RR:NC:N3:143
CATEGORY: OriginLawrence PilonRock Trade Law LLC134 N LaSalle Street, Suite 1800Chicago, IL 60602RE: The country of origin of disposable hubbed hypodermic needlesDear Mr. Pilon:In your letter dated
May 21, 2026
, you requested a country of origin ruling of disposable hubbed hypodermicneedles on behalf of Sandstone Medical (Suzhou) Inc. The products under consideration are disposable, hubbed, hypodermic needles designed for use with injectionpen devices for self-administration. They are available in two styles: “Easydrip Classic” and “Easydrip Plus.”Each hubbed needle, regardless of style, features a beveled and sharpened, thin wall, silicone-coated stainlesssteel hypodermic needle that is securely glued to an injection-molded plastic hub. The hub is threaded toallow attachment to compatible reusable self-injection devices manufactured by various companies thataccept compatibly threaded pen needles. These needles are available in gauges ranging from 29G to 33G(0.33 mm to 0.20 mm nominal outside diameter) and in lengths from 4 mm to 13 mm. As noted, the hubbedhypodermic needles are imported into the United States packaged for retail sale in boxes containing 100needles.You describe the manufacturing process as follows:The manufacture of sharpened stainless steel hypodermic needles occurs in Slovakia or Thailand,starting with thin-walled surgical stainless-steel tubing (31G or 32G, approximately 0.26 mm or 0.24mm nominal outside diameter). The tubing is inspected for quality, straightened, and cut to preciselengths. In Slovakia or Thailand, the tip of each cut needle is ground and beveled through multipleoperations to achieve its final sharpened point: a 3-bevel tip for Easydrip Classic or a 5-bevel tip forEasydrip Plus. The number of bevels impacts the penetration force required, with the 5-bevel tipoffering a smoother and more comfortable injection experience. You state that these operationsrequire specialized machinery and skilled technicians. At this stage, the needles are finished andsuitable only for integration into threaded plastic hubs for pen needle devices. The finished needlesare then packaged and shipped in bulk to China for further processing.
In China, the finished stainless steel hypodermic needles are cleaned and glued into injection-moldedplastic hubs of Chinese origin. A light coating of protective silicone oil is applied, and both the innerand outer plastic caps (also of Chinese origin) are attached. These steps are performed throughrepetitive, mechanically automated assembly line processes.After assembly, in China, the hubbed needles are inspected, sealing paper is applied over the outercap, and the needles are gamma sterilized. The finished products are then packaged into retailformats—typically boxes of 50, 100, or 200 units—for shipment to the United States.As noted, the cost of the beveled and ground stainless steel hypodermic needles varies slightly depending onthe gauge of the needle, with larger gauges generally costing more than smaller ones. In every case, theneedle itself represents the dominant portion of the value of the finished hubbed needle, accounting for80%-90 of the material cost, 69%-79% of the total manufacturing cost, and 60%- 70% of the final packagedand sterilized product cost. When determining the country of origin for purposes of applying ordinary most favored nation duties, currenttrade 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 asubstantial 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. SeeNational Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).In this case, all processing steps that occur in China—attaching the hubs to the stainless steel needles withglue, applying a light silicone coating, attaching the plastic caps, sterilizing, and packaging—which areconsidered simple and minor operations, do not result in a substantial transformation of the stainless steelneedles. The stainless steel needles are the raison d'être of the disposable hubbed hypodermic needles that areused to inject fluids into or withdraw fluids from parts of the body below the surface of the skin. Therefore,the country of origin of the disposable hubbed hypodermic needles is Slovakia or Thailand, depending on thecountry of origin of the stainless steel hypodermic needles.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Dionisia Melman at [email protected].
Sincerely,
(for)James P. ForkanDirectorNational Commodity Specialist Division