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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 K213058
Device Name O'Star Nitrile Examination Gloves Powder Free
Applicant
Star Investment And Trade Joint Stock Company
Khac Niem Industrial Cluster, Khac Niem Ward
Bac Ninh,  VN 16000
Applicant Contact Do Van Binh
Correspondent
Liberty Management Group Limited
75 Executive Drive, Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/22/2021
Decision Date 02/08/2022
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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