GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim And With Tested For Use With Chemotherapy Drugs Claims

Polymer Patient Examination Glove

ECO Medi Glove SDN BHD

The following data is part of a premarket notification filed by Eco Medi Glove Sdn Bhd with the FDA for Gen 2 Nitrile Examination Glove (blue) With Low Dermatitis Potential Claim And With Tested For Use With Chemotherapy Drugs Claims.

Pre-market Notification Details

Device IDK193121
510k NumberK193121
Device Name:GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim And With Tested For Use With Chemotherapy Drugs Claims
ClassificationPolymer Patient Examination Glove
Applicant ECO Medi Glove SDN BHD Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, Perak,  MY 34600
ContactSuresh Kumar
CorrespondentSuresh Kumar
ECO Medi Glove SDN BHD Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, Perak,  MY 34600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-12
Decision Date2020-03-20

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