BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Disposable Vinyl Examination Gloves

    K Number: K223008 · Decision Oct 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    795
    Applicant Total
    2
    Review Days
    9

    Basic Information

    Device Name
    Disposable Vinyl Examination Gloves
    K Number
    K223008
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangxi Handspro Products Solutions CO., LTD.
    Date Received
    September 29, 2022
    Decision Date
    October 8, 2022
    Product Code
    LYZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYZ Vinyl Patient Examination Glove

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LYZ), ordered by most recent decision date.

    Disposable Vinyl Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Vinyl examination gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Disposable Powder Free Vinyl Examination Gloves, Beige/Clear

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Disposable, vinyl examination gloves, Yellow

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Jiangxi Handspro Products Solutions CO., LTD.

    K Number Device Name
    K223004 Disposable Nitrile Examination Gloves