The following data is part of a premarket notification filed by Tactyl Technologies, Inc. with the FDA for Tactylon Tm Surgical Glove.
| Device ID | K902831 |
| 510k Number | K902831 |
| Device Name: | TACTYLON TM SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
| Contact | Buddenhagen |
| Correspondent | Buddenhagen TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-28 |
| Decision Date | 1990-07-10 |