Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Vinyl Patient Examination Glove

Shandong Jieshi Medical Products Co.,Ltd

The following data is part of a premarket notification filed by Shandong Jieshi Medical Products Co.,ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).

Pre-market Notification Details

Device IDK210774
510k NumberK210774
Device Name:Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
ClassificationVinyl Patient Examination Glove
Applicant Shandong Jieshi Medical Products Co.,Ltd North Road, Fumin Avenue, Qinghe Street, Caoxian County Heze,  CN 274400
ContactLi Biao
CorrespondentChu Xiaoan
Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 Of Southern Dou Ge Zhuang, Chaoyung District Beijing,  CN 100121
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2021-05-14

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