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510(k) Data Aggregation

    K Number
    K980942
    Device Name
    REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE
    Manufacturer
    LONDON INTERNATIONAL GROUP, INC.
    Date Cleared
    1998-05-11

    (60 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A Sterile surgeon's Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures.

    Device Description

    Sterile Indicator Inner Surgeon's Glove

    AI/ML Overview

    The provided text is a 510(k) clearance letter for a medical device (Regent Biogel Indicator Inner Surgical Glove). It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

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