Nitrile Examination Golves Powder Free

Polymer Patient Examination Glove

Jiangsu Standard Health Co.,Ltd

The following data is part of a premarket notification filed by Jiangsu Standard Health Co.,ltd with the FDA for Nitrile Examination Golves Powder Free.

Pre-market Notification Details

Device IDK212921
510k NumberK212921
Device Name:Nitrile Examination Golves Powder Free
ClassificationPolymer Patient Examination Glove
Applicant Jiangsu Standard Health Co.,Ltd 19F Fortune Tower, No.1 Wangxi Road Zhangjiagang City,  CN 215600
ContactLu Tao
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-14
Decision Date2021-12-24

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