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

    POWDER FREE NITRILE EXAMINATION GLOVES

    K Number: K022619 · Decision Sep 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES
    K Number
    K022619
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ar Alliance Healthcare Sdn. Bhd.
    Date Received
    August 7, 2002
    Decision Date
    September 6, 2002
    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 Ar Alliance Healthcare Sdn. Bhd.

    K Number Device Name
    K022572 NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
    K020838 ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K020359 ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES