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510(k) Data Aggregation

    K Number
    K994246
    Device Name
    OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
    Manufacturer
    Date Cleared
    2000-01-31

    (46 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIGRACE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    OmniGrace Nitrile, Blue, Examination Glove, Powder Free, Polymer Coated.
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    K Number
    K993419
    Device Name
    OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    Date Cleared
    1999-11-19

    (38 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIGRACE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)
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    K Number
    K993050
    Device Name
    OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
    Manufacturer
    Date Cleared
    1999-11-09

    (60 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIGRACE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    OmniGrace Nitrile, Green, Examination Glove, Powder Free, Polymer Coated.
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    K Number
    K991845
    Device Name
    PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
    Manufacturer
    Date Cleared
    1999-08-05

    (69 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIGRACE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Not Found
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    K Number
    K991846
    Device Name
    PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
    Manufacturer
    Date Cleared
    1999-08-05

    (69 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIGRACE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Patient Examination Glove, Nitrile, Powdered, Turquoise
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    K Number
    K983730
    Device Name
    OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE
    Manufacturer
    Date Cleared
    1998-12-11

    (50 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIGRACE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent / moundal you between health care personnel and the patient.
    Device Description
    Omni Flex Nitrile Examination Glove, Powder Free, Blue
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    K Number
    K983725
    Device Name
    OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE
    Manufacturer
    Date Cleared
    1998-12-07

    (46 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIGRACE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Omni Touch Nitrile Examination Glove, Powdered, Blue
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    K Number
    K973134
    Device Name
    OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED
    Manufacturer
    Date Cleared
    1997-11-06

    (77 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIGRACE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Patient Examination Glove - Om Ni. FIT , LATEx TownEzFil EXAMINATION GLOVE.
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