K253398
- 510(k) number
- K253398
- Device name
- Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
- Applicant
- Efofex, Inc. AR · US
- Product code
- FXX — Mask, Surgical
- Decision date
- 2026-02-19
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253398.pdf
Official FDA record: K253398
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.