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510(k) Data Aggregation

    K Number
    K103650
    Device Name
    NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM
    Date Cleared
    2011-03-23

    (99 days)

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

    OON CORP. RESOURCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Powder-Free Patient Examination Glove is a Disposable Device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Non-Sterile, Powder-Free Blue Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or less) Non-Sterile, Powder-Free Blue Latex Examination Gloves with Bubble Gum Scent and Protein Labeling Claim (50 Micrograms or less) Non-Sterile, Powder-Free Blue Latex Examination Gloves with Grape Scent and Protein Labeling Claim (50 Micrograms or less)
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    K Number
    K093496
    Device Name
    NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT
    Date Cleared
    2010-02-03

    (85 days)

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

    OON CORP. RESOURCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVE WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN LABELING CLAIM (50 micrograms or less) IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES, WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN CONTENT LABELING CLAIM (50 Micrograms or Less)
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    K Number
    K002448
    Device Name
    LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
    Date Cleared
    2000-09-11

    (33 days)

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

    OON CORP. RESOURCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K981917
    Device Name
    POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Date Cleared
    1998-12-07

    (189 days)

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

    OON CORP. RESOURCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT (50 MICROGRAMS OR LESS)
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    K Number
    K970770
    Device Name
    LATEX EXAMINATION GLOVES
    Date Cleared
    1997-07-14

    (133 days)

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

    OON CORP. RESOURCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON-THE EXAMINER*S WAND TO PREVENT CONTAMINATION™ BETWEEN PATIENT AND EXAMINER.
    Device Description
    POWDER-FREE LATEX EXAMINATION GLOVES
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