The following data is part of a premarket notification filed by Copioumed Intl., Inc. with the FDA for Powdered Vinyl Exam Gloves, White.
| Device ID | K030927 |
| 510k Number | K030927 |
| Device Name: | POWDERED VINYL EXAM GLOVES, WHITE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | COPIOUMED INTL., INC. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker COPIOUMED INTL., INC. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-04-17 |
| Summary: | summary |