The following data is part of a premarket notification filed by Regent Medical with the FDA for Regent Biogel Surgical Glove, Biogel M Glove.
| Device ID | K970924 |
| 510k Number | K970924 |
| Device Name: | REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | REGENT MEDICAL 2926 COLUMBIA HIGHWAY PO BOX 8308 Dothan, AL 36304 |
| Contact | Neil Anderson |
| Correspondent | Neil Anderson REGENT MEDICAL 2926 COLUMBIA HIGHWAY PO BOX 8308 Dothan, AL 36304 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-04-01 |