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510(k) Data Aggregation

    K Number
    K212649
    Device Name
    Disposable Surgical Face Mask
    Manufacturer
    Lyncmed Medical Technology (Beijing) Co., Ltd.
    Date Cleared
    2022-10-25

    (428 days)

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

    Lyncmed Medical Technology (Beijing) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
    Device Description
    The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
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    K Number
    K211586
    Device Name
    Nitrile Examination Gloves (Blue, Violet)
    Manufacturer
    Lyncmed Medical Technology (Beijing) Co., Ltd.
    Date Cleared
    2021-11-01

    (161 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lyncmed Medical Technology (Beijing) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Examination Gloves is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    The proposed device, Nitrile Examination Gloves (Blue, Violet) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Violet. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
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