Disposable Nitrile Examination Gloves (Powder Free, Blue)

Polymer Patient Examination Glove

Leping Shengde Medical Technology Company Limited

The following data is part of a premarket notification filed by Leping Shengde Medical Technology Company Limited with the FDA for Disposable Nitrile Examination Gloves (powder Free, Blue).

Pre-market Notification Details

Device IDK211581
510k NumberK211581
Device Name:Disposable Nitrile Examination Gloves (Powder Free, Blue)
ClassificationPolymer Patient Examination Glove
Applicant Leping Shengde Medical Technology Company Limited No.17, Yubao Village, Lingang Village Committee, Lingang Town, Leping City Jingdezhen,  CN 333300
ContactSheng Jianchao
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-21
Decision Date2021-10-28

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