The following data is part of a premarket notification filed by Depuy-raynham with the FDA for Lifeliner Surgical Glove.
| Device ID | K910941 |
| 510k Number | K910941 |
| Device Name: | LIFELINER SURGICAL GLOVE |
| Classification | Dress, Surgical |
| Applicant | DEPUY-RAYNHAM P.O. BOX 988 Warsaw, IN 46580 |
| Contact | David A Kotkovetz |
| Correspondent | David A Kotkovetz DEPUY-RAYNHAM P.O. BOX 988 Warsaw, IN 46580 |
| Product Code | FYE |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-05-09 |