ANSELL CONFORM GREEN EXAMINATION GLOVES

Vinyl Patient Examination Glove

ANSELL, INC.

The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Ansell Conform Green Examination Gloves.

Pre-market Notification Details

Device IDK897081
510k NumberK897081
Device Name:ANSELL CONFORM GREEN EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant ANSELL, INC. P.O. BOX 18 LAT KRABANG, BANGKOK 10520 Thailand,  TH
ContactJohn W Moushall
CorrespondentJohn W Moushall
ANSELL, INC. P.O. BOX 18 LAT KRABANG, BANGKOK 10520 Thailand,  TH
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-19
Decision Date1990-03-26

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