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510(k) Data Aggregation

    K Number
    K984066
    Device Name
    OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM
    Manufacturer
    Date Cleared
    1999-01-13

    (58 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A glove to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    OmniGrip Latex Surgeons Gloves, Powder Free WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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    K Number
    K984064
    Device Name
    OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
    Manufacturer
    Date Cleared
    1999-01-08

    (53 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A glove to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Not Found
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