Powder Free Nitrile Examination Gloves, (Cobalt Blue And Violet Blue), Powder Free Latex Examination Gloves

Polymer Patient Examination Glove

Zibo Blue Sail Health Technology Co., Ltd

The following data is part of a premarket notification filed by Zibo Blue Sail Health Technology Co., Ltd with the FDA for Powder Free Nitrile Examination Gloves, (cobalt Blue And Violet Blue), Powder Free Latex Examination Gloves.

Pre-market Notification Details

Device IDK221229
510k NumberK221229
Device Name:Powder Free Nitrile Examination Gloves, (Cobalt Blue And Violet Blue), Powder Free Latex Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Zibo Blue Sail Health Technology Co., Ltd No.1888 Honghua Road, High Technical Area Zibo,  CN 255400
ContactXu Shulong
CorrespondentXu Shulong
Zibo Blue Sail Health Technology Co., Ltd No.1888 Honghua Road, High Technical Area Zibo,  CN 255400
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-29
Decision Date2022-07-16

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