FDA Product Code
FDA Product Code FYE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K932731 | BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN | Johnson & Johnson Medical, Inc. | 1994-04-11 | Traditional | PDF ↗ |
| K912790 | SURGICAL GOWN | Unicor Federal Dept. of Justice | 1991-09-19 | Traditional | PDF ↗ |
| K910920 | PROTEKT GLOVES | Intermedics Orthopedics | 1991-05-15 | Traditional | PDF ↗ |
| K910941 | LIFELINER SURGICAL GLOVE | Depuy-Raynham | 1991-05-09 | Traditional | PDF ↗ |
| K895667 | STERILE SURGICAL GOWN | Clinitech, Inc. | 1989-10-13 | Traditional | PDF ↗ |
| K895235 | VARIOUS DISPOSABLE SURGICAL GARMENTS | Protect Corp. of Indiana, Inc. | 1989-09-19 | Traditional | PDF ↗ |
| K894760 | CLOTHINGUARD | Barrier Concepts, Inc. | 1989-08-18 | Traditional | PDF ↗ |
Product code FYE · Class I · General, Plastic Surgery. Data: openFDA.