LZC · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6250
Classification
FDA Product Code
LZC
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.6250
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.