PROTECTIVE RADIOGRAFIC GLOVE
FDA 510(k) clearance K920538 · decided 1992-05-29
Clearance details
- K-number
- K920538
- Device name
- PROTECTIVE RADIOGRAFIC GLOVE
- Applicant
- Burkhart Roentgen Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-05
- Decision date
- 1992-05-29
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- IWP
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Pinellas Park, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. (K904878) | Hpi, Inc. | 1991-03-07 |
| HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES (K905086) | Hpi, Inc. | 1990-12-03 |
| RADIATION PROTECTION GLOVES (K900972) | Infab Corp. | 1990-05-01 |
| IMAGEN CHLAMYDIA TEST (K844683) | Boots-Celltech Diagnostics, Inc. | 1985-02-06 |
Recalls involving this device
No recalls on record reference this clearance.