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510(k) Data Aggregation

    K Number
    K203064
    Device Name
    ICU Health Surgical Mask
    Manufacturer
    Plastikon Industries
    Date Cleared
    2021-03-23

    (165 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K160269
    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. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

    Device Description

    The surgical mask is composed of three-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, white), filter middle layer (polypropylene melt-blown, white) and inner layer (spunbond polypropylene, white). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria for ASTM Level 2Reported Device Performance (Surgical Mask - K203064 Level 2)Acceptance Criteria for ASTM Level 3Reported Device Performance (Surgical Mask - K203064 Level 3)
    Fluid Resistance (ASTM F1862-17)Pass @ 120 mmHgPass @ 120 mmHgPass @ 160 mmHgPass @ 160 mmHg
    Particulate Filtration Efficiency (PFE) (ASTM F2299)≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 2)Pass @ 99.8%≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 3)Pass @ 99.8%
    Bacterial Filtration Efficiency (BFE) (ASTM F2101-19)≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 2)Pass @ >99%≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 3)Pass @ >99%
    Differential Pressure (EN 14683:2019 Annex C)
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