Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown— 510(k) K211422

Substantially Equivalent

Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

FDA 510(k) clearance K211422 for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown, Substantially Equivalent on 2021-07-02. Applicant: Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. Device class: 2.

Clearance details

Applicant
Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.
Product code
Code FYA
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Siyang, CN
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