Nitrile Exam Gloves (Blue, Black)

Polymer Patient Examination Glove

Hebei Astro Medical Supply Co., Ltd.

The following data is part of a premarket notification filed by Hebei Astro Medical Supply Co., Ltd. with the FDA for Nitrile Exam Gloves (blue, Black).

Pre-market Notification Details

Device IDK221143
510k NumberK221143
Device Name:Nitrile Exam Gloves (Blue, Black)
ClassificationPolymer Patient Examination Glove
Applicant Hebei Astro Medical Supply Co., Ltd. East Of Xiaoxixian, West Of Jingsan Street, South Of Weiwu Road, North Of Weiqi Road, Jinzhou Eco Jinzhou,  CN 052260
ContactNing Zheng
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd. P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-20
Decision Date2022-08-25

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