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

    BIOSHIELD AND UNIVERSAL LATEX EXAM GLOVES

    K Number: K891268 · Decision Aug 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    166

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    Basic Information

    Device Name
    BIOSHIELD AND UNIVERSAL LATEX EXAM GLOVES
    K Number
    K891268
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Dah Lee Rubber Industries (Thai) , Ltd.
    Date Received
    March 9, 1989
    Decision Date
    August 22, 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 Dah Lee Rubber Industries (Thai) , Ltd.

    K Number Device Name
    K895448 RUBBER LATEX SURGICAL GLOVES, STERILE