KGO · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4460
Classification
FDA Product Code
KGO
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 878.4460
Review panel
HO
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.