510(k) DEN120022
DEN120022 is an FDA 510(k) premarket notification submitted by Bloxr Corporation for the device "X-RAY ATTENUATING CREAM". The FDA issued a decision of De Novo Granted on May 9, 2013. The device falls under product code PDK (Cream For X-Ray Attenuation), a Class II device regulated under 21 CFR 892.6510. Bloxr Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 9, 2013
- Date Received
- November 7, 2012
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cream For X-Ray Attenuation
- Device Class
- Class II
- Regulation Number
- 892.6510
- Review Panel
- RA
- Submission Type
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.