Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4040
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.