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510(k) Data Aggregation

    K Number
    K201844
    Device Name
    Surgical Face Mask, Surgical Mask
    Manufacturer
    Lear Corporation
    Date Cleared
    2021-07-14

    (373 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K201479
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healthcare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single use, disposable device.

    Device Description

    The proposed Surgical Face Mask is a non-sterile, single-use, 3-layer mask with outer and inner facing layers comprised of white spun-bond polypropylene and a middle layer comprised of white melt blown polypropylene. The mask is secured to the user via nylon/spandex ear loops that are ultrasonically welded to the mask. This mask does not contain any natural rubber latex. The device also contains a nose wire made of a pliable steel strip, coated in polypropylene, that helps to form the mask around the user’s nose.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance Criteria (ASTM F2100-19 Level 3)Reported Device Performance (K201844)Predicate Device Performance (K201479)
    Fluid Resistance (ASTM F1862)160 mmHgPassPass
    Particulate Filtration Efficiency (ASTM F2299, 0.1 micron)≥ 98%Avg. 99.0%≥ 99%
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%Avg. 99.1%≥ 99%
    Differential Pressure (EN 14683:2019, Annex C)
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