POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES

Latex Patient Examination Glove

ANSELL, INC.

The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Powder Free, Hypoallergenic Ambidextrous Patient Examination Gloves.

Pre-market Notification Details

Device IDK945767
510k NumberK945767
Device Name:POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES
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 Received1994-11-21
Decision Date1995-03-02

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