PDK

Cream For X-Ray Attenuation

Product code

PDK

Device name

Cream For X-Ray Attenuation

Device class

Class 2

21 CFR

21 CFR 892.6510

Medical specialty

Radiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).