Radiographic Protective Glove
Device Code: 5293
Product Code(s):
IWP Definition: A Protective Radiographic Glove Is A "personnel Protective Shield." The Gloves Are Intended To Protect The Operator, Patient, Or Other Person From Unnecessary Exposure To Radiation During Radiological Procedures By Providing An Attenuating Barrier To
Device Classification Information
| Device Type ID | 5293 |
| Device Name | Radiographic Protective Glove |
| Regulation Description | Personnel Protective Shield. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 892.6500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IWP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5293 |
| Device | Radiographic Protective Glove |
| Product Code | IWP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Personnel Protective Shield. |
| CFR Regulation Number | 892.6500 [🔎] |
| Device Problems |
|---|
Defective Device | 3 |
| Total Device Problems | 3 |
TPLC Last Update: 2019-04-02 21:03:48