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.

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
No devices found for this product code.

About Product Code PDK - Regulatory Context