Cleared Traditional

Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)

K232812 · Owens & Minor (O&M) Halyard, Inc. · General Hospital
Jun 2024
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K232812 is an FDA 510(k) clearance for the Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116), 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 14, 2024, 276 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 K232812 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2023
Decision Date June 14, 2024
Days to Decision 276 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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