POWDERED VINYL EXAM GLOVES, WHITE

Vinyl Patient Examination Glove

COPIOUMED INTL., INC.

The following data is part of a premarket notification filed by Copioumed Intl., Inc. with the FDA for Powdered Vinyl Exam Gloves, White.

Pre-market Notification Details

Device IDK030927
510k NumberK030927
Device Name:POWDERED VINYL EXAM GLOVES, WHITE
ClassificationVinyl Patient Examination Glove
Applicant COPIOUMED INTL., INC. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434 -9550
ContactJanna P Tucker
CorrespondentJanna P Tucker
COPIOUMED INTL., INC. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434 -9550
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-24
Decision Date2003-04-17
Summary:summary

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