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510(k) Data Aggregation

    K Number
    K232777
    Device Name
    FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
    Manufacturer
    Owens & Minor (O&M) Halyard, Inc.
    Date Cleared
    2024-07-01

    (294 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K110455
    Why did this record match?
    Device Name :

    FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.

    Device Description

    The subject devices are ASTM F2100 Level 1 (lavender in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. The FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nose foam. These masks are single use, disposable devices, provided non-sterile.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (face masks) and describes non-clinical performance testing against established standards, not a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.

    However, I can extract the acceptance criteria and reported device performance from the non-clinical testing summary as requested:

    1. A table of acceptance criteria and the reported device performance

    TestPurposeAcceptance CriteriaReported Device Performance (Result)
    ASTM F2101 (Bacterial Filtration Efficiency)To demonstrate adequate bacterial filtration efficiencyUnder the conditions of the study, at least 95% efficiencyPass (≥ 95%)
    EN 14683:2019+AC Annex C (Breathability)To demonstrate acceptable breathabilityUnder the conditions of the study, at most 5.0 mm H2O/cm²Pass (
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