Device type
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Product code QPC · Class II · 21 CFR 878.4040 · General, Plastic Surgery
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.
Recent 510(k)s
Sep 11, 2026
K262007
PRIMED AAMI Level 3 Open Back Gowns
PRIMED Medical Products, Inc.
- QPC
- Class II
Recent recalls
No recalls in the archive for QPC.