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

    SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE

    K Number: K130450 · Decision Sep 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    7
    Review Days
    585

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    Basic Information

    Device Name
    SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE
    K Number
    K130450
    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
    Purna Bina Sdn Bhd
    Date Received
    February 22, 2013
    Decision Date
    September 30, 2014
    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 Purna Bina Sdn Bhd

    K Number Device Name
    K083571 ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
    K041004 ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
    K022659 ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)
    K003904 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
    K994420 POWDER FREE LATEX EXAMINATION PATIENT GLOVES
    K891507 PATIENT EXAMINATION GLOVES (LATEX)