K905086 is an FDA 510(k) clearance for the HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES. This device is classified as a Radiographic Protective Glove (Class I - General Controls, product code IWP).
Submitted by Hpi, Inc. (Newton Centre, US). The FDA issued a Cleared decision on December 3, 1990, 19 days after receiving the submission on November 14, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500. 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 Radiation. Note: These Devices Are Not Patient Examination Gloves Or Surgeon's Gloves. -.
| 510(k) Number | K905086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1990 |
| Decision Date | December 03, 1990 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWP — Radiographic Protective Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.6500 |
| 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 Radiation. Note: These Devices Are Not Patient Examination Gloves Or Surgeon's Gloves. - |