Medical Nitrile Examination Gloves (Model: JL001)

Polymer Patient Examination Glove

Guangdong Jiali Pharmaceutical Co.,Ltd

The following data is part of a premarket notification filed by Guangdong Jiali Pharmaceutical Co.,ltd with the FDA for Medical Nitrile Examination Gloves (model: Jl001).

Pre-market Notification Details

Device IDK213848
510k NumberK213848
Device Name:Medical Nitrile Examination Gloves (Model: JL001)
ClassificationPolymer Patient Examination Glove
Applicant Guangdong Jiali Pharmaceutical Co.,Ltd Dawei, Niugutian Villagers Committee, Muzhou Town, Xinhui Jiangmen,  CN 529143
ContactJiali Chen
CorrespondentCassie Lee
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huang District Guangzhou,  CN
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-10
Decision Date2022-03-25

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