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 |