FYE
7 FDA 510(k) clearances · Product code
64 daysmedian time to decision
308 days90th percentile
7clearances measured
FDA profile
- Official device name
- Dress, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2001: 1 · 2002: 2 · 2003: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| VARIOUS DISPOSABLE SURGICAL GARMENTS (K895235) | Protect Corp. of Indiana, Inc. | 1989-09-19 |
| CLOTHINGUARD (K894760) | Barrier Concepts, Inc. | 1989-08-18 |
Track FYE automatically
Every clearance here is in the API, with alerts when new ones post.