The following data is part of a premarket notification filed by Glormed Intl., Inc. with the FDA for Powder-free-vinyl Examination Gloves, Color: White.
| Device ID | K021353 |
| 510k Number | K021353 |
| Device Name: | POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | GLORMED INTL., INC. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker GLORMED INTL., INC. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-26 |
| Decision Date | 2002-06-06 |
| Summary: | summary |