Nitrile Examination Gloves

Polymer Patient Examination Glove

Zhenjiang Huayang Latex Products Co., Ltd.

The following data is part of a premarket notification filed by Zhenjiang Huayang Latex Products Co., Ltd. with the FDA for Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK210106
510k NumberK210106
Device Name:Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Zhenjiang Huayang Latex Products Co., Ltd. Lianhe Village, Xinba Town Yangzhong,  CN 212212
ContactHan Sheng
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-15
Decision Date2021-04-07

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