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    K Number
    K192374
    Device Name
    Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
    Manufacturer
    Cardinal Health 200, LLC
    Date Cleared
    2019-12-02

    (94 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K140155
    Why did this record match?
    Device Name :

    Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip

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

    The Cardinal Health™ Level 3 surgical masks with Anti-Fog Foam Strip 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™ Level 3 surgical masks are single use, disposable devices provided non-sterile.

    Device Description

    The Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a four-layer mask constructed of 1 layer of nonwoven polyester/polyethylene blend (inner facing), 1 layer of nonwoven polyolefin melt blown (filter media), 1 layer of nonwoven polyester/polyethylene blend (middle layer), 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 attached by ultrasonic welding. A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The Anti-Fog Foam Strip is intended to minimize fogging.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study conducted for the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (K192374).

    Here's the breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestPurposeAcceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%)Reported Device Performance (Test Results)Average Performance
    ASTM F1862 Synthetic BloodDetermine synthetic blood penetration resistance160 mmHgPass (31/32)N/A
    ASTM F2101 BFEDetermine the bacterial filtration efficiency≥ 98%Pass (32/32)99.7%
    ASTM F2299 PFE at 0.1 micronDetermine sub-micron particulate filtration efficiency≥ 98%Pass (32/32)99.2%
    Mil-M-36954C Delta PDetermine breathing resistance or differential pressure
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