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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 K221185
Device Name TC Gloves
Applicant
Thanh Cong Pharmaceutical and Trading Company Limited
KM6+ 200 National Road No. 38, Hap Linh
Bac Ninh City,  VN
Applicant Contact Nguyen Thi Tu Anh
Correspondent
Liberty Management Group Limited
75 Executive Drive, Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/25/2022
Decision Date 06/22/2022
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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