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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K172930
Device Name mCare Powder-free Blue Nitrile Examination Gloves
Applicant
Mercator Medical (Thailand), Ltd.
88/2 Moo 12 Tambon Kampaengphet
Amphur Rattaphum,  TH
Applicant Contact Dariusz Jan Krezymon
Correspondent
Mercator Medical (Thailand), Ltd.
88/2 Moo 12 Tambon Kampaengphet
Amphur Rattaphum,  TH
Correspondent Contact Dariusz Jan Krezymon
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/25/2017
Decision Date 04/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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