Powder Free Vinyl Patient Examination Gloves

Vinyl 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 Powder Free Vinyl Patient Examination Gloves.

Pre-market Notification Details

Device IDK210799
510k NumberK210799
Device Name:Powder Free Vinyl Patient Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Yunnan Huazhiyuan Medical Technology Co., Ltd. Yangjie Industrial Park, Jianshui County Honghe Hani And Yi Autonomous Prefecture,  CN 654300
ContactYun Gao
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-16
Decision Date2021-05-14

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