CBP Reclassified Gloves as Non-Medical Despite Meeting FDA Requirements, Importer Says

CBP “without explanation” reclassified imported nitrile rubber gloves as non-medical gloves and subjected them to a 3% duty rate, despite the gloves meeting all FDA requirements for medical gloves, their importer said in a complaint filed at the Court of International Trade May 22 (SW Technologies v. U.S., CIT # 23-00119).

SW Technologies said it made the gloves to medical specifications, such as not including powder and having a very quality standard. It also obtained 510(k) clearance from the FDA to market the gloves as medical devices, and the manufacturers of the gloves were registered as medical device manufacturers. The packaging was labeled in line with medical glove labeling regulations, and SW Technologies included partner government agency message set data for FDA-regulated medical devices in its entry documentation.

Though SW Technologies had entered the gloves under duty-free subheading 4015.19.0550 of the Harmonized Tariff Schedule as medical gloves, CBP subsequently rate advanced the gloves under subheading 4015.19.1010, a basket provision for “other,” non-medical gloves.

That’s despite a series of CBP rulings holding that “the differences between medical and non-medical gloves can be discerned by reference to the regulatory framework surrounding medical gloves,” including FDA quality and pre-market clearance requirements, SW Technologies said.

“Accordingly, the medical gloves at issue are classifiable under Subheading 4015.19.0550, HTSUS, and SW Technologies is entitled to a refund of all unlawful duties assessed and paid, together with all applicable interest,” the importer said.