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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 K190942
Device Name Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
Applicant
Ever Growth (Vietnam) Co. Ltd.
Long Khanh Industrial Zone Binhloc Village
Binhloc Village,  VN 810000
Applicant Contact Ming Lee
Correspondent
Elizabeth Deng
5748 Eaglewood Place, Rancho Cucamonga
Rancho Cucamonga,  CA  91730
Correspondent Contact Elizabeth Deng
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/10/2019
Decision Date 01/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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