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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name patient examination glove, specialty
510(k) Number K193555
Device Name Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
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 Place
ranch cucamonga,  CA  91730
Correspondent Contact elizabeth deng
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Codes
LZA   QDO  
Date Received12/20/2019
Decision Date 06/04/2020
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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