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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 K222813
Device Name Nitrile Examination Gloves
Applicant
Ecoglove Medical Manufacturing Company Limited
A Part Of Land Plot # 679, Map # 41,
N4 St., Bau Bang Hamlet
Lai Uyen Town, Bau Bang District,  VN
Applicant Contact Nguyen Anh Tu
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 Received09/19/2022
Decision Date 03/16/2023
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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