Surgical and medical examination gloves are regulated as Class I or Class II medical devices by FDA. Importers must ensure the manufacturer is registered with FDA, the device is listed, and the product meets applicable performance standards (e.g., ASTM F1671 for surgical gloves). FDA may detain shipments that lack proper registration or labeling. Consult a licensed customs broker or regulatory affairs specialist to confirm current admissibility requirements.

Classification of composite gloves follows the essential character test under GRI 3(b). If the plastic component provides the primary protective or functional characteristic, classification under 3926.20 is supported. If the textile component predominates by weight, surface area, or function, a textile heading in Section XI may apply. CBP has issued rulings on specific glove constructions, so checking the CROSS database for analogous rulings is advisable before large-volume importation.