POWDER FREE SURGEON'S GLOVE
FDA 510(k) clearance K944054 · decided 1994-11-17
Clearance details
- K-number
- K944054
- Device name
- POWDER FREE SURGEON'S GLOVE
- Applicant
- Arent Fox
- Decision
- Substantially Equivalent
- Date received
- 1994-08-19
- Decision date
- 1994-11-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KGD
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Washington, DC, 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 |
|---|---|---|
| CHISELS- FREER, LUCAS, ALEXANDER, BISHOP (K891902) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
Recalls involving this device
No recalls on record reference this clearance.