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 In
| Device Type ID | 5422 |
| Device Name | Cream For X-ray Attenuation |
| Physical State | X-ray Attenuating Cream |
| Technical Method | The Device Consists Of A Non-toxic, Non-heavy Metal, Radiation Absorbing Material In A Formulated Base. Radiation Is Blocked By The Device Via Absorption Of The Photon Energy From Ionizing Radiation. This Photon Energy Is Dissipated As Phonon Energy |
| Target Area | Healthcare Professional's Hands |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.6510 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5422 |
| Device | Cream For X-ray Attenuation |
| Product Code | PDK |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 892.6510 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BLOXR CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |