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

    NITRILE EXAMINATION GLOVES, PRE-POWDERED

    K Number: K023979 · Decision Jan 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    53

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    Basic Information

    Device Name
    NITRILE EXAMINATION GLOVES, PRE-POWDERED
    K Number
    K023979
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Starmatrix Sdn Bhd
    Date Received
    December 2, 2002
    Decision Date
    January 24, 2003
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by Starmatrix Sdn Bhd

    K Number Device Name
    K023715 STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
    K023978 NITRILE EXAMINATION GLOVES, POWDER FREE
    K023977 PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM