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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 K213016
Device Name ATM Glove
Applicant
Phu Duc Huy Production Trading Services Corporation
Hamlet 8, Luong Hoa Commune
Ben Luc District,  VN 82000
Applicant Contact Tran Xuan Kiem
Correspondent
Liberty Management Group Limited
75 Executive Dr., Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/20/2021
Decision Date 12/28/2021
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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