Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)— 510(k) K253398
Substantially EquivalentEfofex, Inc.
FDA 510(k) clearance K253398 for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300), Substantially Equivalent on 2026-02-19. Applicant: Efofex, Inc.. Device class: 2.
Summary
Efofex's Disposable Surgical Mask (Non-Sterile) carries EFX3PLBLKMSK300 in parentheses in its name. It's filed under product code FXX, surgical mask, and the record doesn't describe the mask further.
Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Special 510(k), though the record lists General, Plastic Surgery as the classification panel.
Efofex filed from Rogers, Arkansas. The substantially equivalent decision came 142 calendar days after receipt (September 30, 2025 to February 19, 2026).
Clearance details
- Applicant
- Efofex, Inc.
- Product code
- Product code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rogers, AR, US
Recent devices under product code FXX
view allMore clearances from Efofex, Inc.
view allAdverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . 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.