Disposable Surgical Gowns

Gown, Surgical

Anhui Medpurest Medical Technology Co.,Ltd

The following data is part of a premarket notification filed by Anhui Medpurest Medical Technology Co.,ltd with the FDA for Disposable Surgical Gowns.

Pre-market Notification Details

Device IDK202532
510k NumberK202532
Device Name:Disposable Surgical Gowns
ClassificationGown, Surgical
Applicant Anhui Medpurest Medical Technology Co.,Ltd No.188,Wenyuan Road, Zhumeng New Zone Anqing,  CN 246003
ContactLong Shushan
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-01
Decision Date2021-08-21

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