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    K Number
    K220187
    Device Name
    Medical Surgical Mask (Model: JM92, JM92B)
    Manufacturer
    Guangdong Jia Mei Biological technology Co.Ltd
    Date Cleared
    2022-03-25

    (60 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K212293,K211552
    Why did this record match?
    Device Name :

    Medical Surgical Mask (Model: JM92, JM92B)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL 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, provided non-sterile.

    Device Description

    The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of a Medical Surgical Mask (Model: JM92, JM92B) based on non-clinical testing for FDA 510(k) clearance, not a study involving human readers or AI. Therefore, I cannot provide information on points 2, 3, 4, 5, 8, and 9 as they are not applicable to this type of device submission.

    Here is the information from the document related to acceptance criteria and device performance:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test ItemTest MethodAcceptance Criteria for Level 1Acceptance Criteria for Level 3Reported Device Performance (Verdict)
    Bacterial filtration efficiencyASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100: 2019≥ 95%≥ 98%Pass
    Differential pressure (Delta-P)EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100: 2019
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