Disposable Medical Face Mask (M643BE)— 510(k) K240258

Substantially Equivalent

Makrite Industries, Inc.

FDA 510(k) clearance K240258 for Disposable Medical Face Mask (M643BE), Substantially Equivalent on 2024-04-18. Applicant: Makrite Industries, Inc..

Clearance details

Applicant: Makrite Industries, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2024-01-31
Decision date: 2024-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei, 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.