IWP · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.6500
Classification
FDA Product Code
IWP
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 892.6500
Review panel
RA
Medical specialty
Radiology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -