FDA Medical Device Class I

FDA Registration - Latex and Nitrile gloves

FDA regulates latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration, and device listing to market in the USA. Powdered gloves are not allowed to market in the USA for medical purposes.

FDACE PRO Provide assistance to latex and nitrile glove manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

Prepare 510k notification

Submission of 510k notification

FDA Agent service for 510k submission

Guidance in test requirements

Register your medical device establishment with FDA

List your glove with FDA.

FDA Classification for examination and surgical gloves