Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)— 510(k) K253398

Substantially Equivalent

Efofex, Inc.

FDA 510(k) clearance K253398 for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300), Substantially Equivalent on 2026-02-19. Applicant: Efofex, Inc..

Clearance details

Applicant: Efofex, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2025-09-30
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Rogers, AR, US

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.