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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 K190876
Device Name mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Applicant
Mercator Medical (Thailand), Ltd.
88/8, 88/9 Moo 12 Tambon Kampaengphet
Amphur Rattaphum,  TH 90180
Applicant Contact Dariusz Jan Krezymon
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received04/04/2019
Decision Date 12/02/2019
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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