PDK — Cream For X-Ray Attenuation Class II
FDA product code PDK covers "Cream For X-Ray Attenuation", a Class II medical device regulated under 21 CFR 892.6510. Submissions are reviewed by the Radiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PDK
- Device Class
- Class II
- Regulation Number
- 892.6510
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.