To help alleviate supply pressures and increase availability of these products to the U.S. market, the FDA may consider expedited review of manufacturing site changes (if you are a class III device manufacturer), or premarket submissions—manufacturers of PPE.
The applicable product codes are:
Surgical gowns (FYA)
Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
Surgical suits (FXO)
In this review, known as Premarket Notification or 510(k) clearance, the manufacturers have to show they meet specific criteria for performance, labeling, and intended use, to demonstrate substantial equivalence.
One way substantial equivalence may be demonstrated, in part, is by conforming to consensus standards for barrier performance and resistance to tears and snags. Voluntary consensus standards may also be used to demonstrate sterility (when applicable), biocompatibility, fluid resistance, and flammability.
Manufacturers must validate the methods used to test conformance to standards and support each product with appropriate performance test data.
To identify FDA-cleared products, search the 510(k) Premarket Notification database using the product codes for gowns (FYA, FYB, FYC).
At this time, FDA has not cleared, approved, or authorized any gowns or surgical masks for specific protection or prevention against the virus that causes COVID-19.
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.
If you are a part of a group purchasing organization (GPO), or a manufacturer in China, India, Mexico, Europe, you may want to contact ITB HOLDINGS LLC.