BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE

Latex Patient Examination Glove

MULTISAFE SDN BHD

The following data is part of a premarket notification filed by Multisafe Sdn Bhd with the FDA for Blue Powder Free Latex Examination Gloves, Non-sterile.

Pre-market Notification Details

Device IDK062527
510k NumberK062527
Device Name:BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
ClassificationLatex Patient Examination Glove
Applicant MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE Bidor, Perak,  MY 35500
ContactAbd Hadi Bin Husin
CorrespondentAbd Hadi Bin Husin
MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE Bidor, Perak,  MY 35500
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-28
Decision Date2007-02-20
Summary:summary

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