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

    AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM

    K Number: K013953 · Decision Feb 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
    K Number
    K013953
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Supermax Glove Manufacturing Sdn Bhd
    Date Received
    November 30, 2001
    Decision Date
    February 26, 2002
    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 Supermax Glove Manufacturing Sdn Bhd

    K Number Device Name
    K024083 GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
    K014230 STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
    K013589 CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
    K010198 STERILE POWDERED LATEX SURGEON GLOVES
    K000644 SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES