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

Polymer Patient Examination Glove

Zibo Yahao Supplies Co., LTD

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

Pre-market Notification Details

Device IDK182612
510k NumberK182612
Device Name:Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue And Violet Blue)
ClassificationPolymer Patient Examination Glove
Applicant Zibo Yahao Supplies Co., LTD The 6th Floor, NO.8, Niushan Road, Linzi Area Zibo,  CN 255414
ContactFiona Xin
CorrespondentFiona Xin
Zibo Yahao Supplies Co., LTD The 6th Floor, NO.8, Niushan Road, Linzi Area Zibo,  CN 255414
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-21
Decision Date2019-05-10

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