FDA 510(k) clearance · back to tracker

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

Efofex, Inc. cleared K253398 on 2026-02-19, decision: substantially equivalent

K-number

K253398

Sponsor

Efofex, Inc.

Device

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-02-19

Product code

FXX

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4040

Official FDA record

Open K253398on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.