Nitrile Patient Examination Gloves

Polymer Patient Examination Glove

Huayuan Medical Technology(Shangqiu) Co., Ltd.

The following data is part of a premarket notification filed by Huayuan Medical Technology(shangqiu) Co., Ltd. with the FDA for Nitrile Patient Examination Gloves.

Pre-market Notification Details

Device IDK211028
510k NumberK211028
Device Name:Nitrile Patient Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Huayuan Medical Technology(Shangqiu) Co., Ltd. In The North Yard Of West 1000m Road At The Intersection Of Zhuangzhou Avenue And Pingyuan Road, Liangyuan District Shangqiu,  CN 476000
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-06
Decision Date2021-06-04

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