K253398 is an FDA 510(k) clearance for the Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Efofex, Inc. (Rogers, US). The FDA issued a Cleared decision on February 19, 2026, 142 days after receiving the submission on September 30, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K253398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2025 |
| Decision Date | February 19, 2026 |
| Days to Decision | 142 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |