Medical Gloves

Polymer Patient Examination Glove

Beijing Biosis Healing Biological Technology Co., Ltd.

The following data is part of a premarket notification filed by Beijing Biosis Healing Biological Technology Co., Ltd. with the FDA for Medical Gloves.

Pre-market Notification Details

Device IDK203622
510k NumberK203622
Device Name:Medical Gloves
ClassificationPolymer Patient Examination Glove
Applicant Beijing Biosis Healing Biological Technology Co., Ltd. Valley No.1 Bio-medicine Industry Park, Daxing District Beijing,  CN 102600
ContactTing Jiang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-11
Decision Date2021-08-20

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