HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE

Latex Patient Examination Glove

ANSELL, INC.

The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Hypoallergenic Powdered Ambidextrous Coagulatn Dipped Latex Examination Glove.

Pre-market Notification Details

Device IDK953379
510k NumberK953379
Device Name:HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE
ClassificationLatex Patient Examination Glove
Applicant ANSELL, INC. 1500 INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan,  AL  36302
ContactKay Smith
CorrespondentKay Smith
ANSELL, INC. 1500 INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan,  AL  36302
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-19
Decision Date1995-09-27

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