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510(k) Data Aggregation

    K Number
    K052387
    Device Name
    ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2005-11-29

    (90 days)

    Product Code
    LZB
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arthrex Fingershield finger guards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.
    Device Description
    The Arthrex Fingershield Finger Guards are woven polyester with a marker thread of radio opaque Micropake®. These are offered in a one size fits all cylinder shape. They are offered sterile.
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    K Number
    K992539
    Device Name
    PERCUGUARD
    Manufacturer
    DIGIT-PRO
    Date Cleared
    2000-02-18

    (203 days)

    Product Code
    LZB
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of PERCUGUARD ™ is to prevent accidental needle stick and/or sharps injuries to healthcare workers on the fingers and thumbs exposed lo injuries. It is a protective finger guard accessory to the examination glove. It is used on the finger and/or the thumb of the non-dominant hand usually used to retract, stabilize. or isolate in preparation for an injection procedure. Il may be inverted and used to prevent accidental needle sticks while suluring. It can be used on the dominant hand (device inverted) when isolating, retracting, stabilizing, or palpating tissue where sharp bone or wires are present in order to protect the palm side of the fingers or thumbs
    Device Description
    Not Found
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    K Number
    K980827
    Device Name
    LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
    Manufacturer
    TUCKER & ASSOCIATES
    Date Cleared
    1998-05-04

    (62 days)

    Product Code
    LZB
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A finger cot is a disposable device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner.
    Device Description
    Latex Finger Cot, Powder-Free, with Protein Labeling
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