BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)

    K Number: K891726 · Decision May 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    6
    Review Days
    50

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    Basic Information

    Device Name
    VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)
    K Number
    K891726
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Baldur Systems Corp.
    Date Received
    March 23, 1989
    Decision Date
    May 12, 1989
    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

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    K891728 LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)
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