Cleared Traditional

Disposable Surgical Face Mask (K223823) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223823 · Efofex, Inc. · General Hospital
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Mar 2023
Decision
96d
Days
Class 2
Risk

K223823 is an FDA 510(k) clearance for the Disposable Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Efofex, Inc. (Rogers, US). The FDA issued a Cleared decision on March 27, 2023 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Efofex, Inc. devices

Submission Details

510(k) Number K223823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 129d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Mdi Consultants
Timothy Kania

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K223823.
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 )
K230569 · Cardinalhealth · Jul 2023
Surgical Face Mask (L 175*95mm)
K230617 · Henan Chaoya Medical Equipment Co., Ltd. · Jun 2023
Disposable Medical Mask
K222545 · Guangzhou Fuzelong Hygiene Material Co., Ltd. · May 2023
Medline Surgical Face Mask and Medline Procedural Face Mask
K223236 · Medline Industries, LP · Mar 2023
Surgical Face Mask
K221352 · Wuhan Huashida Protective Products Co., Ltd. · Mar 2023
PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
K221209 · Padm Medical, Inc. · Mar 2023