C2 MEDICAL GLOVES

Polymer Patient Examination Glove

AMERCARE, INC.

The following data is part of a premarket notification filed by Amercare, Inc. with the FDA for C2 Medical Gloves.

Pre-market Notification Details

Device IDK113639
510k NumberK113639
Device Name:C2 MEDICAL GLOVES
ClassificationPolymer Patient Examination Glove
Applicant AMERCARE, INC. 611 W. 5TH STREET THIRD FLOOR Austin,  TX  78701
ContactAndrew Lowery
CorrespondentAndrew Lowery
AMERCARE, INC. 611 W. 5TH STREET THIRD FLOOR Austin,  TX  78701
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-09
Decision Date2012-05-08
Summary:summary

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