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Found 12 results

510(k) Data Aggregation

    K Number
    K012402
    Device Name
    OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
    Date Cleared
    2001-10-12

    (77 days)

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

    OMNIGRACE (THAILAND) 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
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    K Number
    K002922
    Device Name
    OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)
    Date Cleared
    2000-10-16

    (27 days)

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

    OMNIGRACE (THAILAND) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K993479
    Device Name
    OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)
    Date Cleared
    1999-11-19

    (36 days)

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

    OMNIGRACE (THAILAND) 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, Powdered, with Protein Claim (100 Micrograms or Less)
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    K Number
    K990696
    Device Name
    OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE
    Date Cleared
    1999-05-13

    (71 days)

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

    OMNIGRACE (THAILAND) 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
    Omni Flex Nitrile Examination Glove, Powder Free
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    K Number
    K990698
    Device Name
    OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE
    Date Cleared
    1999-05-13

    (71 days)

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

    OMNIGRACE (THAILAND) 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
    Omni Touch Nitrile Examination Glove, Powdered, Purple
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    K Number
    K990701
    Device Name
    OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE
    Date Cleared
    1999-05-05

    (63 days)

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

    OMNIGRACE (THAILAND) 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
    Omni Flex Nitrile Examination Glove, Powder Free, Purple
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    K Number
    K990695
    Device Name
    OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE
    Date Cleared
    1999-05-04

    (62 days)

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

    OMNIGRACE (THAILAND) 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
    Omni Touch Nitrile Examination Glove, Powdered, White
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    K Number
    K990702
    Device Name
    OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM
    Date Cleared
    1999-05-04

    (62 days)

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

    OMNIGRACE (THAILAND) 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 ( 50ug or less )
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    K Number
    K982716
    Device Name
    OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM
    Date Cleared
    1998-11-30

    (118 days)

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

    OMNIGRACE (THAILAND) 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
    OmniGrace Latex Examination Glove, Powder Free, with Protein Claim
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    K Number
    K982613
    Device Name
    OMNI PRO LATEX SURGICAL GLOVE, POWDERED
    Date Cleared
    1998-09-02

    (37 days)

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

    OMNIGRACE (THAILAND) LTD.

    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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