EMG Powder Free Nitrile Examination Glove (Blue) With Peppermint Scented

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 Powder Free Nitrile Examination Glove (blue) With Peppermint Scented.

Pre-market Notification Details

Device IDK152937
510k NumberK152937
Device Name:EMG Powder Free Nitrile Examination Glove (Blue) With Peppermint Scented
ClassificationPolymer Patient Examination Glove
Applicant ECO MEDI GLOVE SDN. BHD. LOT 23826, JALAN TEMBAGA KUNING, KAMUNTING RAYA INDUSTRIAL ESTATE Kumunting Perak,  MY 34600
ContactSuresh Kumar
CorrespondentSuresh Kumar
ECO MEDI GLOVE SDN. BHD. LOT 23826, JALAN TEMBAGA KUNING, KAMUNTING RAYA INDUSTRIAL ESTATE Kumunting Perak,  MY 34600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-05
Decision Date2016-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10304040057008 K152937 000
H658103330124 K152937 000
H658103330225 K152937 000
H658103330326 K152937 000
H658103334128 K152937 000
10304040056964 K152937 000
10304040056971 K152937 000
10304040056988 K152937 000
10304040056995 K152937 000
H658103330023 K152937 000

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