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510(k) Data Aggregation

    K Number
    K202708
    Device Name
    Surgical Face Masks
    Manufacturer
    Intco Medical(HK) Co., Ltd.
    Date Cleared
    2021-03-30

    (195 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K201729
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Surgical Face Masks 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 intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

    Device Description

    Surgical Face Masks 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 intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

    The surgical face masks are single use multi-laver masks with outer laver and inner laver of polypropylene spunbond that sandwich a meltblown polypropylene filter material. The surgical face mask includes malleable aluminum nosepiece that can be bent to contour the nose. The surgical face masks are held in place with ear loops made of polyester/Lycra.

    AI/ML Overview

    The information provided describes the acceptance criteria and performance of a Surgical Face Mask (K202708), comparing it to a predicate device (K201729).

    Here's a breakdown of the requested information:

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

    CriteriaAcceptance Criteria (Predicate/Standard)Reported Device Performance (K202708)Outcome
    Fluid Resistance (ASTM F1862)Fluid Resistant at 80 mmHgLot 20201013: Passed 80 mmHg
    Lot 20201022: Passed 80 mmHg
    Lot 20201105: Passed 80 mmHgMeets
    Particulate Filtration Efficiency (PFE) (ASTM F2299)≥ 95%Lot 20201013: PASSED 99.866%
    Lot 20201022: PASSED 99.9784%
    Lot 20201105: PASSED 99.9879%Meets (Exceeds)
    Bacterial Filtration Efficiency (BFE) (ASTM F2101)≥ 95%Lot 20201013: PASSED 99.9%
    Lot 20201022: PASSED 99.9%
    Lot 20201105: PASSED 99.9%Meets (Exceeds)
    Differential Pressure (EN 14683 Annex C)
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