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510(k) Data Aggregation

    K Number
    K213347
    Device Name
    ADI Medical Surgical Face Mask
    Manufacturer
    Asia Dynamics Inc., d/b/a ADI Medical
    Date Cleared
    2022-01-25

    (109 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K202513
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ADI Medical Surgical Masks are 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 the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

    Device Description

    The ADI Medical Surgical Face Masks are single use, three-layer, flat -folded masks with ear loops and nose clamp. The ADI Medical Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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 clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. ADI Medical Surgical Face Masks will be provided in blue. ADI Medical Surgical Face Masks are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    The provided text describes the regulatory filing for a surgical face mask, not an AI-powered diagnostic device. Therefore, the questions related to AI device performance, expert ground truth, MRMC studies, and training/test set sample sizes are not directly applicable.

    However, I can extract the information relevant to the device's acceptance criteria and the study proving it meets those criteria based on the provided document.

    Device: ADI Medical Surgical Face Mask
    Regulatory Filing: K213347

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the ADI Medical Surgical Face Mask are defined by various ASTM and EN standards for surgical masks. The performance tests were conducted to demonstrate that the device meets these standards.

    Table of Acceptance Criteria and Reported Device Performance:

    Performance Test (Standard)Acceptance CriteriaReported Device Performance (ADI Medical Surgical Face Mask)Result
    Fluid Resistance (ASTM F1862)29 out of 32 samples pass at 120 mmHg94 out of 96 samples pass at 120 mmHg (from 3 non-consecutive lots)PASS
    Particulate Filtration Efficiency (ASTM F2299)≥ 98%Average: 99.47% (96 out of 96 samples pass)PASS
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%Average: 99.48% (96 out of 96 samples pass)PASS
    Differential Pressure (Delta P) (EN 14683 Annex C)
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