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510(k) Data Aggregation

    K Number
    K232968
    Device Name
    Grande Medical Masks, Model SF-600
    Manufacturer
    Golden Grande Corp.
    Date Cleared
    2024-06-06

    (259 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K160269
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Grande Medical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The Grande Medical Masks are single use, disposable device, provided non-sterile.

    Device Description

    Grande Medical Masks are 4-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer 1, surface layer 2 and middle layer, and is provided with ear loops and nose clip.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "Grande Medical Masks, Model SF-600".

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance Criteria (F2100-19 Level 2)Reported Device PerformanceResult
    Bacteria Filtration Efficiency (ASTM F2101)≥ 98 %Pass at 99 %Pass
    Particle Filtration Efficiency (ASTM F2299)≥ 98 %Pass at 99%Pass
    Differential Pressure (EN 14683:2019)
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