Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown

Gown, Surgical

Jiangsu Medplus Non-woven Manufacturer Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Medplus Non-woven Manufacturer Co., Ltd. with the FDA for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown.

Pre-market Notification Details

Device IDK211422
510k NumberK211422
Device Name:Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
ClassificationGown, Surgical
Applicant Jiangsu Medplus Non-woven Manufacturer Co., Ltd. No.217 East Wencheng Road, Economic Development Zone Siyang,  CN 223700
ContactShuying An
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-07
Decision Date2021-07-02

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