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    K Number
    K140155
    Device Name
    SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Date Cleared
    2014-06-20

    (149 days)

    Product Code
    FXX,PRE
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K111402
    Why did this record match?
    Device Name :

    SECURE-GARD SURGICAL AND PROCEDURE FACE MASK

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

    Cardinal Health Secure-Gard® surgical and procedure masks are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Secure-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.

    Device Description

    The Cardinal Health Secure-Gard® surgical and procedure masks are all the same four-layer masks constructed of 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polvolefin melt blown (media). 1 laver of nonwoven polyester/polvethylene blends (media), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties or polyester-spandex earloops (both attached by ultrasonic welding). A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The surgical masks will be provided with or without an eye shield. Cardinal Health surgical and procedure masks are a single use, disposable device provided non-sterile.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study detailed in the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%)Reported Device Performance (Current device test results)Average Performance
    ASTM F1862 Synthetic Blood (Resistance to Penetration)160 mmHg32/32 PassNot Applicable
    ASTM F2101 BFE (Bacterial Filtration Efficiency)≥ 98%32/32 Pass99.4 - 99.7%
    ASTM F2299 PFE at 0.1 micron (Particle Filtration Efficiency)≥ 98%32/32 Pass98.6 - 99.1%
    Mil-M-36954C Delta P (Differential Pressure / Breathability)
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