Vinyl Exam Gloves

Vinyl 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 Vinyl Exam Gloves.

Pre-market Notification Details

Device IDK213019
510k NumberK213019
Device Name:Vinyl Exam Gloves
ClassificationVinyl 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, Jinxhou Eco Jinzhou,  CN 052260
ContactNing Zheng
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-20
Decision Date2022-01-05

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