BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇭 Thailand

    PATIENT EXAMINATION GLOVE

    K Number: K891619 · Decision Aug 9, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    145

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOVE
    K Number
    K891619
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Union Rubber Gloves Co., Ltd.
    Date Received
    March 17, 1989
    Decision Date
    August 9, 1989
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Union Rubber Gloves Co., Ltd.

    K Number Device Name
    K891629 PATIENT EXAMINATION GLOVES (LATEX)