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510(k) Data Aggregation

    K Number
    K012199
    Device Name
    DIGICAP
    Manufacturer
    HUMANA USA, INC.
    Date Cleared
    2001-12-19

    (159 days)

    Product Code
    GAB, KGO
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUMANA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DigiCap™ is a protective finger guard accessory to the surgeon's glove. 1. Intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. DigiCap™ is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures. 2. Facilitate suture handling and placement.
    Device Description
    The DigiCAP is an accessory to surgeon's gloves. This product is made from a resin and is of a rigid configuration whereas surgeons gloves are usually prepared from latex or vinyl materials.
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