Gown, Non-Sterile, Non-Isolation, Intended to Provide Moderate or High Barrier Protection

What Is This Device?

A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.

What Is FDA Product Code QPC?

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection is FDA product code QPC, Class 2, 21 CFR 878.4040.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 450 days from receipt to decision on them.