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510(k) Data Aggregation

    K Number
    K214087
    Device Name
    Medical Face Mask
    Manufacturer
    Hubei Medlink Healthcare Co., Ltd
    Date Cleared
    2022-03-08

    (71 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K201729
    Predicate For
    K222809
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is 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 Medical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

    The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond 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 Malleable polyethylene wire.

    The medical face masks are available in five sizes, 17.59.5cm, 15.59.5cm, 14.59.5cm, 149.5cm.

    The medical face masks are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    The provided text is related to the FDA 510(k) clearance for a Medical Face Mask. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than focusing on AI/ML-driven device performance. Therefore, many of the requested elements for describing an AI-powered device's acceptance criteria and study cannot be directly extracted from this document, as they are not applicable to the type of device (medical face mask) being discussed.

    However, I can extract the acceptance criteria and performance data relevant to this medical face mask:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodologyPurposeAcceptance Criteria (ASTM F2100 Level 1)Reported Device Performance
    Fluid Resistance (ASTM F1862)Demonstrate functionality29 out of 32 per lot pass at 80 mmHgPass (32 out of 32 pass at 80 mmHg, 3 lots)
    Particulate Filtration Efficiency (ASTM F2299)Demonstrate functionality$\ge$ 95%Pass (> 95%)
    Bacterial Filtration Efficiency (ASTM F2101)Demonstrate functionality$\ge$ 95%Pass (> 99%)
    Differential Pressure (Delta P) (EN 14683 Annex C)Demonstrate functionality
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