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510(k) Data Aggregation

    K Number
    K220187
    Device Name
    Medical Surgical Mask (Model: JM92, JM92B)
    Date Cleared
    2022-03-25

    (60 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Jia Mei Biological technology Co.Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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