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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 K213286
Device Name EONS Nitrile Examination Gloves Powder Free
Applicant
Eons Gloves (Thailand) Co., Ltd
486/14 Moo 9 Nai Klong Bang Pla Kot
Phra Samut Chedi,  TH 10290
Applicant Contact Gliaophan Supharkarn
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 Received10/01/2021
Decision Date 02/19/2022
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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