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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    DIGIT-PRO

    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
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