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

    POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

    K Number: K994416 · Decision Feb 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    36

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    Basic Information

    Device Name
    POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    K Number
    K994416
    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
    December 29, 1999
    Decision Date
    February 3, 2000
    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 Flexitech Sdn. Bhd.

    K Number Device Name
    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)
    K990499 PREPOWDERED NITRILE EXAMINATION GLOVES
    K990495 POWDER FREE NITRILE EXAMINATION GLOVES