Cleared Abbreviated

Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804) (K243010) - FDA 510(k) Clearance

Also marketed or referenced as:
Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208) Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207) Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237) Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247) Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797) Fluidshield * 3 Fog-Free Proce

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K243010 · Owens & Minor (O&M) Halyard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
246d
Days
Class 2
Risk

K243010 is an FDA 510(k) clearance for the Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Owens & Minor (O&M) Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on May 30, 2025 after a review of 246 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Owens & Minor (O&M) Halyard, Inc. devices

Submission Details

510(k) Number K243010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2024
Decision Date May 30, 2025
Days to Decision 246 days
Submission Type Abbreviated
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
117d slower than avg
Panel avg: 129d · This submission: 246d
Pathway characteristics
Standards-based clearance path.

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 Peers - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K243010.
PRIMED Surgical and Procedure Masks
K252964 · Primed Medical Products, Inc. · Nov 2025
Vitaform Procedural Mask - Blue (Vitaform Blue)
K251902 · Vitacore Industries, Inc. · Sep 2025
Procedure mask/Surgical mask/Face mask
K250082 · Winner Medical Co., Ltd. · Jun 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
PRIMED Surgical Masks and PRIMED Procedure Masks
K240286 · Primed Medical Products, Inc. · Aug 2024