Nitrile Patient Examination Gloves (Tested For Use With Chemotherapy Drugs)

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 (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK213048
510k NumberK213048
Device Name:Nitrile Patient Examination Gloves (Tested For Use With Chemotherapy Drugs)
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 R Shangqiu,  CN 476000
ContactHuamei Wang
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-22
Decision Date2021-12-18

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