Rubber Gloves

Yes. Rubber gloves intended for medical use — including examination and surgical gloves — are regulated by FDA as Class I or Class II medical devices. The foreign manufacturer must be registered with FDA, and the products must comply with applicable performance standards. Shipments may be detained at the port of entry if the manufacturer is not registered or if the gloves fail to meet labeling requirements. Consult a licensed customs broker or regulatory counsel familiar with FDA device imports before shipping.

This heading covers gloves of vulcanized rubber (including natural latex and synthetic rubber compounds). Gloves made of plastics such as nitrile or vinyl, which are chemically distinct from rubber, fall under the plastics apparel heading rather than here. The material composition — confirmed by supplier technical data sheets — is the controlling factor, and misidentifying nitrile as rubber is a common classification error.