Nitrile Examination Gloves Powder Free (Blue)

Polymer Patient Examination Glove

Great Eco Glove Sdn. Bhd.

The following data is part of a premarket notification filed by Great Eco Glove Sdn. Bhd. with the FDA for Nitrile Examination Gloves Powder Free (blue).

Pre-market Notification Details

Device IDK210868
510k NumberK210868
Device Name:Nitrile Examination Gloves Powder Free (Blue)
ClassificationPolymer Patient Examination Glove
Applicant Great Eco Glove Sdn. Bhd. Lot 1675, Jalan Makmur, Batu 28, Ijok Bestari Jaya,  MY 45600
ContactSoh Wei Li
CorrespondentShahnaz Sakinah
Great Eco Glove Sdn. Bhd. Lot 1675, Jalan Makmur, Batu 28, Ijok Bestari Jaya,  MY 45600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-23
Decision Date2021-09-02

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