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510(k) Data Aggregation

    K Number
    K042567
    Device Name
    POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E
    Manufacturer
    PT. MEDISAFE TECHNOLOGIES
    Date Cleared
    2005-01-13

    (114 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Powder-Free, Polychloroprene Surgical Gloves with Vera and Vitamin E, Sterile is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    Not Found

    AI/ML Overview

    This appears to be a 510(k) clearance letter from the FDA for a surgical glove. The provided text does not contain any information about acceptance criteria, study details, or device performance data.

    The document primarily focuses on:

    • Device Identification: Trade/Device Name, Regulation Number, Regulatory Class, Product Code.
    • FDA Clearance: Confirmation of substantial equivalence to a predicate device.
    • Regulatory Information: General controls provisions, potential additional controls, contact information for regulatory guidance.
    • Indications for Use: Stating the purpose of the surgical gloves (protection of a surgical wound from contamination).

    Therefore, I cannot provide the requested table and study details based on the given input. To answer your request, I would need a document that includes performance data for the device, such as a summary of safety and effectiveness (SSE) report or a clinical study report that details the testing performed to demonstrate the device meets certain criteria.

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