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510(k) Data Aggregation

    K Number
    K220876
    Device Name
    AOK 95A Medical Mask (20200049)
    Date Cleared
    2022-07-27

    (124 days)

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

    AOK Tooling Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AOK 95A Medical Mask (20200049) is 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The AOK 95A Medical Mask (20200049) is single use, four-layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. 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 AOK 95A Medical Mask will be provided in white and blue. The AOK 95A Medical Mask is sold non-sterile and are intended to be single use, disposable devices.
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    K Number
    K211956
    Device Name
    039 Surgical Face Mask
    Date Cleared
    2021-11-23

    (152 days)

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

    AOK Tooling Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 039 Medical Surgical Face Mask is 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The 039 Medical Surgical Face Mask is single use, four- layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. 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 surgical face masks will be provided in blue. The 039 Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.
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    K Number
    K201517
    Device Name
    Plain Surgical Mask
    Date Cleared
    2020-09-04

    (88 days)

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

    AOK Tooling Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Plain Surgical 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, provided non-sterile.
    Device Description
    The Plain Surgical Face Mask is a single use, three-layer, flat-folded masks with ear loops and adjustable clips and nose piece. The Plain Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbonded 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 and with adjustable clips. 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 surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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