VARIOUS DISPOSABLE SURGICAL GARMENTS
FDA 510(k) clearance K895235 · decided 1989-09-19
Clearance details
- K-number
- K895235
- Device name
- VARIOUS DISPOSABLE SURGICAL GARMENTS
- Applicant
- Protect Corp. of Indiana, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-07
- Decision date
- 1989-09-19
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- FYE
- Device class
- 1
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN (K932731) | Johnson & Johnson Medical, Inc. | 1994-04-11 |
| SURGICAL GOWN (K912790) | Unicor Federal Dept. of Justice | 1991-09-19 |
| PROTEKT GLOVES (K910920) | Intermedics Orthopedics | 1991-05-15 |
| LIFELINER SURGICAL GLOVE (K910941) | Depuy-Raynham | 1991-05-09 |
| STERILE SURGICAL GOWN (K895667) | Clinitech, Inc. | 1989-10-13 |
| CLOTHINGUARD (K894760) | Barrier Concepts, Inc. | 1989-08-18 |
Recalls involving this device
No recalls on record reference this clearance.