Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
QPC · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4040
Classification
FDA Product Code
QPC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4040
Review panel
HO
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.