BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇭 Thailand

    BLACK NITRILE EXAMINATION GLOVES

    K Number: K083908 · Decision Mar 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    9
    Review Days
    66

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    Basic Information

    Device Name
    BLACK NITRILE EXAMINATION GLOVES
    K Number
    K083908
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovative Gloves Co;, Ltd.
    Date Received
    December 30, 2008
    Decision Date
    March 6, 2009
    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 Innovative Gloves Co;, Ltd.

    K Number Device Name
    K111158 LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K103670 NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
    K021668 NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)
    K013333 LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM
    K993567 INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
    K993325 INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
    K993222 INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE
    K993221 INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED