Nitrile Patient Examination Gloves

Polymer Patient Examination Glove

ZHANGJIAGANG FENGYUAN PLASTIC PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Zhangjiagang Fengyuan Plastic Products Co., Ltd. with the FDA for Nitrile Patient Examination Gloves.

Pre-market Notification Details

Device IDK211351
510k NumberK211351
Device Name:Nitrile Patient Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant ZHANGJIAGANG FENGYUAN PLASTIC PRODUCTS CO., LTD. No.333,Fumin Middle Road,Tangqiao Town, Shangqiu,  CN 215615
ContactHuamei Wang
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 Received2021-05-03
Decision Date2021-08-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.