Surgical drapes and gowns intended to prevent infection during procedures are regulated as Class II medical devices by FDA and generally require 510(k) clearance. Importers must confirm that the foreign manufacturer holds the appropriate clearance and is registered with FDA before entry. Products marketed as general-purpose protective clothing without surgical claims may fall outside device regulation.

Importers should have the FDA 510(k) clearance number for the specific device, the foreign manufacturer's FDA establishment registration number, and the device listing number readily available. CBP may transmit entry data to FDA for review, and FDA can place a shipment on detention if registration or clearance records cannot be verified. A commercial invoice clearly identifying the device by model and intended use also facilitates smooth entry.