The following data is part of a premarket notification filed by Bernard Technologies, Inc. with the FDA for (multiple Labels) Powder-free Vinyl Examination Gloves.
| Device ID | K033229 |
| 510k Number | K033229 |
| Device Name: | (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | BERNARD TECHNOLOGIES, INC. 75 EAST WACKER DRIVE Chicago, IL 60601 |
| Contact | Michael D Lelah, Phd |
| Correspondent | Michael D Lelah, Phd BERNARD TECHNOLOGIES, INC. 75 EAST WACKER DRIVE Chicago, IL 60601 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-06 |
| Decision Date | 2003-12-17 |
| Summary: | summary |