The following data is part of a premarket notification filed by Tactyl Technologies, Inc. with the FDA for Patient Examination Glove/hypoallergenic.
| Device ID | K905109 |
| 510k Number | K905109 |
| Device Name: | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC |
| Classification | Patient Examination Glove |
| 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 | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-13 |
| Decision Date | 1990-11-21 |