The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Surgeon's Gloves.
| Device ID | K842884 |
| 510k Number | K842884 |
| Device Name: | SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
| Contact | John Brda |
| Correspondent | John Brda TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1984-11-29 |