Cleared Traditional

K250082 - Procedure mask/Surgical mask/Face mask

K250082 is an FDA 510(k) clearance for Procedure mask/Surgical mask/Face mask, manufactured by Winner Medical Co., Ltd.. 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.

K250082 · Winner Medical Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
156d
Days
Class 2
Risk

K250082 is an FDA 510(k) clearance for the Procedure mask/Surgical mask/Face mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 18, 2025 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 Winner Medical Co., Ltd. devices

FDA 510(k) Submission Details - K250082

510(k) Number K250082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2025
Decision Date June 18, 2025
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 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K250082.
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · O&M Halyard, Inc. · Dec 2025
PRIMED Surgical and Procedure Masks
K252964 · Primed Medical Products, Inc. · Nov 2025
Vitaform Procedural Mask - Blue (Vitaform Blue)
K251902 · Vitacore Industries, Inc. · Sep 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · Owens & Minor (O&M) Halyard, Inc. · May 2025
Aurelia Surgical Mask ASTM Level-3 (2130)
K242502 · Supermax Healthcare Canada-Supermax Medical · Nov 2024
Surgical Face Mask (Tie on/ Ear loops)
K240916 · Xiantao Daoqi Plastic Co., Ltd. · Oct 2024