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

    LATEX EXAMINATION POWDERED GLOVES

    K Number: K993386 · Decision Dec 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    73

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    Basic Information

    Device Name
    LATEX EXAMINATION POWDERED GLOVES
    K Number
    K993386
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Great Glove Sdn Bhd
    Date Received
    October 8, 1999
    Decision Date
    December 20, 1999
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Great Glove Sdn Bhd

    K Number Device Name
    K052955 NITRILE BLUE POWDERED EXAMINATION GLOVES
    K052956 NITRILE BLUE POWDER FREE EXAMINATION GLOVE
    K020363 GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)