MCare(R) Powder Free Nitrile Orange Examination Gloves

Polymer Patient Examination Glove

Mercator Medical (Thailand) LTD.

The following data is part of a premarket notification filed by Mercator Medical (thailand) Ltd. with the FDA for Mcare(r) Powder Free Nitrile Orange Examination Gloves.

Pre-market Notification Details

Device IDK200967
510k NumberK200967
Device Name:MCare(R) Powder Free Nitrile Orange Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Mercator Medical (Thailand) LTD. 88/8 Moo 12 Tambon Kampaengphet Amphur Rattaphum,  TH 90180
ContactDariusz Jan Krezymon
CorrespondentPraneet Inthajak
Mercator Medical (Thailand) LTD. 88/8 Moo 12 Tambon Kampaengphet Amphur Rattaphum,  TH 90180
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-10
Decision Date2020-06-06

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