The following data is part of a premarket notification filed by Maytex Corp. with the FDA for Maytex Powder-free Latex Examination Gloves.
| Device ID | K935315 |
| 510k Number | K935315 |
| Device Name: | MAYTEX POWDER-FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MAYTEX CORP. 25029 VIKING ST. Hayward, CA 94545 |
| Contact | Carlene Hazelton |
| Correspondent | Carlene Hazelton MAYTEX CORP. 25029 VIKING ST. Hayward, CA 94545 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-02 |
| Decision Date | 1994-08-01 |