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510(k) Data Aggregation

    K Number
    K101351
    Device Name
    NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT
    Manufacturer
    Date Cleared
    2010-10-15

    (154 days)

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

    ASCEND EAGLE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These Non-Sterile, Powder-Free Peach Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) 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 PEACH Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent
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    K Number
    K092472
    Device Name
    NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT
    Manufacturer
    Date Cleared
    2010-04-15

    (246 days)

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

    ASCEND EAGLE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These Non-Sterile, Powder-Free, AQUA NITRILE Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) 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, AOUA NITRILE Examination Gloves with Lano- E and Peppermint Citrus Scent
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    K Number
    K052666
    Device Name
    NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN
    Manufacturer
    Date Cleared
    2006-01-25

    (120 days)

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

    ASCEND EAGLE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F and with Protein Labelian Claim (Combined Citrus-Peppermint), and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of 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 Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2.
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