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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K202377
Device Name Palm Care Latex Examination Powder Free Gloves
Applicant
Hi-Care Thai Gloves Co. Ltd.
199Moo.11, T. Banpru
Hat Yai,  TH 90250
Applicant Contact Daniel John
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/20/2020
Decision Date 12/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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