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Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

FDA product code QPC · 12 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4040
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-07-07 – 2026-09-11

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.

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