Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)

Polymer Patient Examination Glove

Tangshan Lanhai Medical Supplies Co., Ltd.

The following data is part of a premarket notification filed by Tangshan Lanhai Medical Supplies Co., Ltd. with the FDA for Disposable Nitrile Examination Gloves (powder Free, Purple-blue, Blue).

Pre-market Notification Details

Device IDK210898
510k NumberK210898
Device Name:Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
ClassificationPolymer Patient Examination Glove
Applicant Tangshan Lanhai Medical Supplies Co., Ltd. South Side Of Zhongda Street, East Side Of Jinxiu Road, Chengxi Industrial Zone, Luannan County Tangshan,  CN 063500
ContactLi Ruidong
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 Received2021-03-26
Decision Date2021-08-26

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