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

    NITRILE EXAMINATION GLOVES-PRE POWDERED

    K Number: K970216 · Decision Sep 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    5
    Review Days
    253

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    Basic Information

    Device Name
    NITRILE EXAMINATION GLOVES-PRE POWDERED
    K Number
    K970216
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Influx Pacific Sdn. Bhd.
    Date Received
    January 16, 1997
    Decision Date
    September 26, 1997
    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 Influx Pacific Sdn. Bhd.

    K Number Device Name
    K980511 NITRILE EXAMINATION GLOVES - POWDER FREE
    K930407 POWDER-FREE LATEX EXAMINATION GLOVES
    K910895 SURGICAL GLOVES
    K891668 PATIENT EXAMINATION GLOVES (LATEX)