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

    SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES

    K Number: K971665 · Decision Jun 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    5
    Review Days
    52

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    Basic Information

    Device Name
    SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES
    K Number
    K971665
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sj Medical Products (M) Sdn Bhd
    Date Received
    May 6, 1997
    Decision Date
    June 27, 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 Sj Medical Products (M) Sdn Bhd

    K Number Device Name
    K971666 SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES
    K971403 SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE
    K941754 POWDER FREE LATEX EXMINATION GLOVES
    K932332 PATIENT EXAMINATION GLOVE - POWDERED