Cleared Traditional

K223236 - Medline Surgical Face Mask and Medline ...

K223236 is an FDA 510(k) clearance for Medline Surgical Face Mask and Medline ..., manufactured by Medline Industries, LP. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K223236 · Medline Industries, LP · General Hospital
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Mar 2023
Decision
156d
Days
Class 2
Risk

K223236 is an FDA 510(k) clearance for the Medline Surgical Face Mask and Medline Procedural Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on March 24, 2023 after a review of 156 days - an extended review cycle.

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 Medline Industries, LP devices

FDA 510(k) Submission Details - K223236

510(k) Number K223236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2022
Decision Date March 24, 2023
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

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 Peers - FXX Mask, Surgical

All 445
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K223236.
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
Disposable Surgical Face Mask
K223823 · Efofex, Inc. · 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
Procedure mask/Surgical mask/Face mask
K223232 · Winner Medical Co., Ltd. · Mar 2023