Cleared Special

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

K253398 · Efofex, Inc. · General Hospital

Feb 2026

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K253398 is an FDA 510(k) clearance for the Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300), 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 review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K253398 FDA.gov
FDA Decision	Cleared 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