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510(k) Data Aggregation

    K Number
    K203012
    Device Name
    Surgical Mask
    Manufacturer
    Customfab, INC.
    Date Cleared
    2021-04-11

    (192 days)

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

    The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use device, provided non-sterile.

    Device Description

    The device is a surgical mask which can be described as non-sterile, single-use, 3 layer, flat-pleated style with ear loops and a nose piece. The outer layer of the surgical mask consists of blue nonwoven spunbond polypropylene and the inner layer consists of carded non-woven polyethylene/polyester. The middle layer consists of melt-blown polypropylene filter. The ear loops consists of 140D nylon and spandex elastic string not made with natural rubber latex. The nose piece is made with white galvanized iron with polyethylene coating.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a Surgical Mask. It details the device's characteristics and its comparison to a predicate device, focusing on non-clinical performance data to establish substantial equivalence.

    Here's an analysis based on your requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test ItemTest MethodAcceptance CriteriaReported Device Performance
    Fluid Resistance PerformanceASTM F1862Fluid resistant, pass at 80 mmHgLot K-1820-01: Pass, 29 of 32 Passed at 80 mmHg
    Lot J-0720-02: Pass, 30 of 32 Passed at 80 mmHg
    Lot J-0920-03: Pass, 29 of 32 Passed at 80 mmHg
    Particulate Filtration EfficiencyASTM F2299/F2299M-03≥95%Lot J-0620-01: Pass, ≥97.6%
    Lot J-0720-02: Pass, ≥98.8%
    Lot J-0920-03: Pass, ≥96.8%
    Bacterial Filtration EfficiencyASTM F2101-01(2019)≥95%Lot J-0620-01: Pass, ≥99.63%
    Lot J-0720-02: Pass, ≥99.74%
    Lot J-0920-03: Pass, ≥99.57%
    Differential Pressure (Delta-P)ASTM F2100-19 (EN 14683)
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