EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)

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 Emg White Nitrile Medical Examination Gloves (powder Free).

Pre-market Notification Details

Device IDK141510
510k NumberK141510
Device Name:EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
ClassificationPolymer Patient Examination Glove
Applicant ECO MEDI GLOVE SDN. BHD LOT 23826, JALAN TEMBAGA KUNING, KAMUNTING RAYA INDUSTRIAL ESTATE Taiping,  MY 34600
ContactSuresh Kumar
CorrespondentSuresh Kumar
ECO MEDI GLOVE SDN. BHD LOT 23826, JALAN TEMBAGA KUNING, KAMUNTING RAYA INDUSTRIAL ESTATE Taiping,  MY 34600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-09
Decision Date2014-10-07
Summary:summary

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