QBW · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4040
Classification
FDA Product Code
QBW
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
Surgical apparel with material claims are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Surgical apparel with material claims contain components that have been constructed, treated, modified, and/or coated with substances that are intended or known to create or enhance a functional element of the device. Examples include fluid repellency, soil retention, or antimicrobial activity.