Cleared Traditional

HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) (K232806) - FDA 510(k) Clearance

Also marketed or referenced as:
HALYARD* Level 1 Procedure Mask (48388)

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

K232806 · Owens & Minor (O&M) Halyard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
269d
Days
Class 2
Risk

K232806 is an FDA 510(k) clearance for the HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloo.... 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 June 7, 2024 after a review of 269 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 Owens & Minor (O&M) Halyard, Inc. devices

Submission Details

510(k) Number K232806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2023
Decision Date June 07, 2024
Days to Decision 269 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
140d slower than avg
Panel avg: 129d · This submission: 269d
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 Peers - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K232806.
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868)
K232777 · Owens & Minor (O&M) Halyard, Inc. · Jul 2024
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)
K232807 · Owens & Minor (O&M) Halyard, Inc. · Jun 2024
Fluidshield* 2 Fog-Free Surgical Mask (62113)
K232812 · Owens & Minor (O&M) Halyard, Inc. · Jun 2024
Grande Medical Masks, Model SF-600
K232968 · Golden Grande Corp. · Jun 2024
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
K232820 · Owens & Minor (O&M) Halyard, Inc. · Jun 2024
Disposable Medical Face Mask (M643BE)
K240258 · Makrite Industries, Inc. · Apr 2024