Nitrile Examination Gloves, Green/ Blue/ Black Color

Polymer Patient Examination Glove

Zhenjiang SuHui Latex Products Co., Ltd.

The following data is part of a premarket notification filed by Zhenjiang Suhui Latex Products Co., Ltd. with the FDA for Nitrile Examination Gloves, Green/ Blue/ Black Color.

Pre-market Notification Details

Device IDK211778
510k NumberK211778
Device Name:Nitrile Examination Gloves, Green/ Blue/ Black Color
ClassificationPolymer Patient Examination Glove
Applicant Zhenjiang SuHui Latex Products Co., Ltd. Lianhe Village, Xinba Town Yangzhong,  CN 212212
ContactZhengfu Sun
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.1601, East Lujiazui Rd., Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-09
Decision Date2021-09-02

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