A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) Premarket Notification.

Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) Premarket Notification

Non-surgical gowns are Class I devices intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination. These products are exempt from 510(k) Premarket Notification.