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.
|Device Name:||Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown|
|Applicant||Jiangsu Medplus Non-woven Manufacturer Co., Ltd. No.217 East Wencheng Road, Economic Development Zone Siyang, CN 223700|
Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|