Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K220469
    Device Name
    Disposable Vinyl Examination Glove
    Manufacturer
    Chifeng Huawei Medical Science&Technology Co.,Ltd.
    Date Cleared
    2022-06-16

    (118 days)

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

    Chifeng Huawei Medical Science&Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DISPOSABLE VINYL EXAMINATION GLOVE is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
    Ask a Question
    K Number
    K212833
    Device Name
    Disposable Nitrile Examination Gloves
    Manufacturer
    Chifeng Huawei Medical Science & Technology Co., Ltd
    Date Cleared
    2022-02-28

    (174 days)

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

    Chifeng Huawei Medical Science & Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Nitrile Examination Gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
    Ask a Question

    Page 1 of 1