OIG · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6250
Classification
FDA Product Code
OIG
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 patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.