PDK · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.6510
Classification
FDA Product Code
PDK
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.6510
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure.