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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 K200967
Device Name mCare(R) Powder Free Nitrile Orange Examination Gloves
Applicant
Mercator Medical (Thailand), Ltd.
88/8 Moo 12 Tambon Kampaengphet
Amphur Rattaphum,  TH 90180
Applicant Contact Dariusz Jan Krezymon
Correspondent
Mercator Medical (Thailand), Ltd.
88/8 Moo 12 Tambon Kampaengphet
Amphur Rattaphum,  TH 90180
Correspondent Contact Praneet Inthajak
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/10/2020
Decision Date 06/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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