K900972 is an FDA 510(k) clearance for the RADIATION PROTECTION GLOVES. This device is classified as a Radiographic Protective Glove (Class I - General Controls, product code IWP).
Submitted by Infab Corp. (Camarillo, US). The FDA issued a Cleared decision on May 1, 1990, 60 days after receiving the submission on March 2, 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 | K900972 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1990 |
| Decision Date | May 01, 1990 |
| Days to Decision | 60 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. - |