Cleared Traditional

Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)

K232807 · Owens & Minor (O&M) Halyard, Inc. · General Hospital
Jun 2024
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K232807 is an FDA 510(k) clearance for the Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802), a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Owens & Minor (O&M) Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on June 21, 2024, 283 days after receiving the submission on September 12, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K232807 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2023
Decision Date June 21, 2024
Days to Decision 283 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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