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510(k) Data Aggregation

    K Number
    K141085
    Device Name
    WestTec Procedure Facemask;WestTec Surgical Facemask
    Manufacturer
    WESTTEC, LLC
    Date Cleared
    2015-03-27

    (333 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K123787
    Predicate For
    K210513
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    West Tec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.

    Device Description

    The WestTec Procedure and Surgical facemasks are identical with the exception that the Surgical Mask has a Comfort Band to keep the inner layer away from the user's mouth to provide space between the users face and the mask making it more comfortable to wear. Both facemasks are manufactured with three layers of nonwoven polypropylene materials. The facemasks are held in place over the user's mouth and nose by two elastic ear loops welded to each facemask. The elastic ear loops are not made with natural rubber latex. The facemasks have a malleable Nose Band contained in the layers of the facemask to allow the user to fit the facemask around their nose. The facemasks are sold non-sterile and are intended to be a single use, disposable device.

    AI/ML Overview

    The document describes the acceptance criteria and study results for WestTec Procedure and Surgical facemasks, which are intended to be substantially equivalent to the predicate device, Jingzhou Haixin Green Cross Medical Products Co., Ltd Surgical Mask (K123787). The devices are classified as Class II surgical apparel under 21 CFR 878.4040.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the WestTec facemasks are based on the ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks for Level 2 performance classification.

    DescriptionASTM F2100 Requirement for Level 2 ClassificationWestTec Masks PerformancePredicate Device (K123787) Performance
    Fluid Resistance Performance ASTM F186229 out of 32 pass at 120mmHg32 out of 32 pass at 120mmHg29 out of 32 pass at 120mmHg
    Particulate Filtration Efficiency ASTM F2299≥98%98.0%99.1%
    Bacterial Filtration Efficiency ASTM F2101≥98%99.7%99.8%
    Differential Pressure (Delta P) MIL-M-36954C
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