BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    ULTIMAX

    K Number: K951473 · Decision Jul 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    61
    Review Days
    109

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    Basic Information

    Device Name
    ULTIMAX
    K Number
    K951473
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wembley Rubber Products (M) Sdn Bhd
    Date Received
    March 30, 1995
    Decision Date
    July 17, 1995
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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    Other Clearances by Wembley Rubber Products (M) Sdn Bhd

    K Number Device Name
    K982600 PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
    K972616 ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
    K972615 CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
    K972621 PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
    K953213 COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
    K962189 COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
    K962188 COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
    K953590 COMFIT
    K960178 COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
    K960407 COMFIT ORTHOPEDIC
    Search all 61 clearances from Wembley Rubber Products (M) Sdn Bhd →