The following data is part of a premarket notification filed by Tactyl Technologies, Inc. with the FDA for Tactylon(tm) Powder Free Surgeons Glove.
| Device ID | K950185 |
| 510k Number | K950185 |
| Device Name: | TACTYLON(TM) POWDER FREE SURGEONS GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
| Contact | Jorge Haider |
| Correspondent | Jorge Haider 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 | 1995-01-17 |
| Decision Date | 1995-04-13 |