The following data is part of a premarket notification filed by Tessile, Inc. with the FDA for Patient Examination Gloves.
| Device ID | K905172 |
| 510k Number | K905172 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TESSILE, INC. C/O SANDLER/TRAVIS & ROSENBERG 5200 BLUE LAGOON DRIVE Miami, FL 33126 |
| Contact | Ellen Rubin |
| Correspondent | Ellen Rubin TESSILE, INC. C/O SANDLER/TRAVIS & ROSENBERG 5200 BLUE LAGOON DRIVE Miami, FL 33126 |
| Product Code | LYY |
| 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 | 1991-01-28 |