Surgical Face Mask— 510(k) K202205

Clearance details

Applicant

Jiangsu Micsafe Medical Technology Co., Ltd.

Product code

Code FXX

Device class

Class 2

Regulation

21 CFR 878.4040

Advisory panel

General, Plastic Surgery

Date received

2020-08-05

Decision date

2021-03-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Yancheng, CN

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Injury

137

Total

137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →