The following data is part of a premarket notification filed by James River Corp. with the FDA for James River Biogel Powderless Surgical Gloves.
| Device ID | K890459 |
| 510k Number | K890459 |
| Device Name: | JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | JAMES RIVER CORP. 1915 MARATHON AVE. Neenah, WI 54956 |
| Contact | Richard L Davis |
| Correspondent | Richard L Davis JAMES RIVER CORP. 1915 MARATHON AVE. Neenah, WI 54956 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-30 |
| Decision Date | 1989-04-20 |