The following data is part of a premarket notification filed by Mayer Laboratories with the FDA for Digitex, Digitex Hypoallergenic.
| Device ID | K926049 |
| 510k Number | K926049 |
| Device Name: | DIGITEX, DIGITEX HYPOALLERGENIC |
| Classification | Latex Patient Examination Glove |
| Applicant | MAYER LABORATORIES 231 FALLON ST. Oakland, CA 94607 |
| Contact | David P Mayer |
| Correspondent | David P Mayer MAYER LABORATORIES 231 FALLON ST. Oakland, CA 94607 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-07-22 |