Cleared Traditional

Disposable Surgical Face Mask

K223823 · Efofex, Inc. · General Hospital

Mar 2023

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K223823 is an FDA 510(k) clearance for the Disposable Surgical Face Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Efofex, Inc. (Rogers, US). The FDA issued a Cleared decision on March 27, 2023, 96 days after receiving the submission on December 21, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K223823 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2022
Decision Date	March 27, 2023
Days to Decision	96 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF