The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Gammex Surgical Gloves.
| Device ID | K802641 |
| 510k Number | K802641 |
| Device Name: | GAMMEX SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL, INC. 1500 INDUSTRIAL RD. Dothan, AL 36303 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-24 |
| Decision Date | 1980-12-11 |