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510(k) Data Aggregation

    K Number
    K980516
    Device Name
    REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE
    Manufacturer
    LONDON INTERNATIONAL GROUP, INC.
    Date Cleared
    1998-04-23

    (72 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 ORTHOPEDIC 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 Orthopediig,Surgeon's Glove WITH PROTENT UNEUNG CLAIM (50 MICROGRAMS or LESS)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about acceptance criteria or a study proving that a device meets those criteria, as typically found in a clinical study report or a detailed pre-market submission.

    Therefore, I cannot provide the requested information. The document is strictly a regulatory clearance for a "Regent Biogel Powder-Free Orthopedic Latex Surgical Glove, with Protein Content Labeling Claim (50 Micrograms or Less)," confirming its substantial equivalence to previously marketed devices.

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