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

    PREPOWDERED NITRILE EXAMINATION GLOVES

    K Number: K990499 · Decision Apr 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    44

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    Basic Information

    Device Name
    PREPOWDERED NITRILE EXAMINATION GLOVES
    K Number
    K990499
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Flexitech Sdn. Bhd.
    Date Received
    February 17, 1999
    Decision Date
    April 2, 1999
    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 Flexitech Sdn. Bhd.

    K Number Device Name
    K994416 POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    K994354 POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K990501 POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
    K990502 PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
    K990495 POWDER FREE NITRILE EXAMINATION GLOVES