BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    K Number: K010881 · Decision May 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    7
    Review Days
    54

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    Basic Information

    Device Name
    UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K Number
    K010881
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    N.S. Uni-Gloves Sdn. Bhd.
    Date Received
    March 23, 2001
    Decision Date
    May 16, 2001
    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 N.S. Uni-Gloves Sdn. Bhd.

    K Number Device Name
    K050765 LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
    K013163 UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
    K010879 UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K000689 UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES
    K000688 UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
    K890965 PATIENT EXAMINATION GLOVES