Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate

Patient Examination Glove, Specialty

Ever Global (Vietnam) Enterprise Corp

The following data is part of a premarket notification filed by Ever Global (vietnam) Enterprise Corp with the FDA for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.

Pre-market Notification Details

Device IDK193555
510k NumberK193555
Device Name:Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate
ClassificationPatient Examination Glove, Specialty
Applicant Ever Global (Vietnam) Enterprise Corp Long Thanh Industrial Zone Taman Village Dong Nai Province,  VN 810000
ContactJerry Lin
CorrespondentElizabeth Deng
Elizabeth Deng 5748 Eaglewood Place Ranch Cucamonga,  CA  91730
Product CodeLZC  
Subsequent Product CodeLZA
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-06-04

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