Surgical Gown

Gown, Surgical

Xianning Marveldas Protective Articles CO.,Ltd.

The following data is part of a premarket notification filed by Xianning Marveldas Protective Articles Co.,ltd. with the FDA for Surgical Gown.

Pre-market Notification Details

Device IDK212812
510k NumberK212812
Device Name:Surgical Gown
ClassificationGown, Surgical
Applicant Xianning Marveldas Protective Articles CO.,Ltd. Guishan Road #30, Hi-New Industrial Xianning,  CN
ContactZhuxiao Kang
CorrespondentSalon Chen
IMD Medical & Drug Technology Service Institutions Room 308, Building 11, No. 23, Jinqu Road, Wanjiang Street Dongguan,  CN 523069
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-03
Decision Date2022-11-16

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