BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    SAMBORD LATEX PATIENT EXAMINATION GLOVES

    K Number: K891644 · Decision Jun 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    94

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    Basic Information

    Device Name
    SAMBORD LATEX PATIENT EXAMINATION GLOVES
    K Number
    K891644
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Polymint Industrial Co. , Ltd.
    Date Received
    March 17, 1989
    Decision Date
    June 19, 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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