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

Polymer Patient Examination Glove

Yunnan Huazhiyuan Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Yunnan Huazhiyuan Medical Technology Co., Ltd. with the FDA for Nitrile Patient Examination Gloves (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK213051
510k NumberK213051
Device Name:Nitrile Patient Examination Gloves (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant Yunnan Huazhiyuan Medical Technology Co., Ltd. Yangjie Industrial Park, Jianshui Country Honghe Hani And Yi Autonomous Prefecture,  CN 654300
ContactYun Gao
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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