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510(k) Data Aggregation

    K Number
    K022256
    Device Name
    SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
    Manufacturer
    TUCKER & ASSOCIATES
    Date Cleared
    2004-04-26

    (654 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K970835
    Why did this record match?
    Device Name :

    SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN

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

    This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

    Device Description

    Non-sterile surgical face mask, white, yellow, pink, blue and green.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided documents:

    Acceptance Criteria and Device Performance

    Performance CharacteristicTest MethodAcceptance CriteriaReported Device Performance
    Fluid ResistanceASTM F-1862-00aNo visual detection of penetrationNo visual detection of penetration
    Filter Efficiency Performance (Microns)Not explicitly statedPassed 2.0 Micron TestPassed 2.0 Micron Test
    Bacterial Filtration Efficiency (BFE) (%)ASTM F-2101-01Not explicitly stated (implied >96.4% from predicate)97.9%
    Differential Pressure (Delta-P)MIL M 36945C4.4.1.1.1Not explicitly stated (implied
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