Powder Free Black Nitrile Examination Glove

Polymer Patient Examination Glove

Vietglove Corporation

The following data is part of a premarket notification filed by Vietglove Corporation with the FDA for Powder Free Black Nitrile Examination Glove.

Pre-market Notification Details

Device IDK201428
510k NumberK201428
Device Name:Powder Free Black Nitrile Examination Glove
ClassificationPolymer Patient Examination Glove
Applicant Vietglove Corporation Cau Sat Hamlet, Lai Hung Commune, Bau Bang District, Binh Duong Province Bingh Duong,  VN 72600
ContactPham Ngoc Thanh
CorrespondentTerence Lim
Vietglove Corporation Cau Sat Hamlet, Lai Hung Commune, Bau Bang District, Binh Duong Province Bingh Duong,  VN 72600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-29
Decision Date2021-06-24

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