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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 K171422
Device Name Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
Applicant
Ever Global (Vietnam) Enterprise Corp
Long Thanh Industrial Zone
Taman Village
Dong Nai Province,  VN 810000
Applicant Contact Jerry Lin
Correspondent
Elizabeth Deng
5748 Eaglewood Pl.
Rancho Cuamonga,  CA  91739
Correspondent Contact Elizabeth Deng
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/15/2017
Decision Date 06/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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