ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G— 510(k) K203376

Substantially Equivalent

Medtecs (Taiwan) Corp.

FDA 510(k) clearance K203376 for ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G, Substantially Equivalent on 2022-03-02. Applicant: Medtecs (Taiwan) Corp..

Clearance details

Applicant: Medtecs (Taiwan) Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-11-17
Decision date: 2022-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.