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510(k) Data Aggregation

    K Number
    K203174
    Device Name
    Disposable Medical Mask
    Manufacturer
    Dong Guan Kinyet Metal Products Co., Ltd
    Date Cleared
    2021-08-02

    (280 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K201137
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Disposable Medical Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

    Device Description

    Disposable Medical Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Mask is sold non-sterile and is intended to be a single use, disposable device.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the "Disposable Medical Mask," based on the provided FDA 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    Fluid Resistance (ASTM F1862)Evaluate fluid resistance performance.Level 3: 160 mm HgAll samples met the predetermined acceptance criteria.
    Bacterial Filtration Efficiency (ASTM F2100-19)Evaluate bacterial filtration efficiency performance.$\geq$ 98%All samples met the predetermined acceptance criteria.
    Differential Pressure (Delta P) (ASTM F2100-19)Evaluate differential pressure performance.
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