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

    OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE

    K Number: K983730 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    8
    Review Days
    50

    Basic Information

    Device Name
    OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE
    K Number
    K983730
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OMNIGRACE LTD.
    Date Received
    October 22, 1998
    Decision Date
    December 11, 1998
    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 OMNIGRACE LTD.

    K Number Device Name
    K994246 OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
    K993419 OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)
    K993050 OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
    K991846 PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
    K991845 PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
    K983725 OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE
    K973134 OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED