PDK · Class II · 21 CFR 892.6510

FDA Product Code PDK: Cream For X-ray Attenuation

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.

Leading manufacturers include Bloxr Corporation.

2
Total
1
Cleared
113d
Avg days
2013
Since

FDA 510(k) Cleared Cream For X-ray Attenuation Devices (Product Code PDK)

2 devices
1–2 of 2
Cleared Jan 13, 2014
ULTRABLOX
K133684
Bloxr Corporation
Radiology · 42d
Not Cleared May 09, 2013
X-RAY ATTENUATING CREAM
DEN120022
Bloxr Corporation
Radiology · 183d

About Product Code PDK - Regulatory Context