Motex Anti-Fog Surgical Face Mask— 510(k) K201549

Substantially Equivalent

Modern Healthcare Corp.

FDA 510(k) clearance K201549 for Motex Anti-Fog Surgical Face Mask, Substantially Equivalent on 2020-08-26. Applicant: Modern Healthcare Corp..

Clearance details

Applicant: Modern Healthcare Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-06-09
Decision date: 2020-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tien-Chung Town, Chang-Hwa County, 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.