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510(k) Data Aggregation

    K Number
    K220532
    Device Name
    Disposable surgical mask
    Manufacturer
    Xiamen Blue Star Enterprise Co., Ltd.
    Date Cleared
    2022-05-23

    (88 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182515
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable surgical masks are intended to be worn to protect 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

    Device Description

    The Disposable surgical masks are single use, three-layer, flat - folded masks with ear loops and nose piece. The Disposable surgical masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric (polypropylene), and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of spandex wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    The provided document describes the FDA 510(k) clearance for a "Disposable surgical mask" (K220532), demonstrating its substantial equivalence to a predicate device. The clearance is based on non-clinical performance testing.

    Here's an analysis of the requested information based on the provided text:

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

    Test ItemAcceptance CriteriaReported Device PerformanceResult
    Fluid Resistance (ASTM F1862)29 out of 32 pass at 120 mmHg3 non-consecutive lots tested: All passed (implied)Pass
    Particulate Filtration Efficiency (ASTM F2299)≥ 98%Lot1: 98.43%, Lot2: 98.18%, Lot3: 98.54%Pass
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%Lot1: 99.9%, Lot2: 99.9%, Lot3: 99.9%Pass
    Differential Pressure (MIL-M-36954C)
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