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510(k) Data Aggregation

    K Number
    K032501
    Device Name
    MAXTER STERILE POWDER FREE SURGICAL GLOVES
    Manufacturer
    MAXTER GLOVE MANUFACTURING SDN BHD
    Date Cleared
    2003-10-17

    (65 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 :

    MAXTER STERILE POWDER FREE SURGICAL GLOVES

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

    A Sterile Powder Free Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    Sterile Powder Free Latex Surgical Gloves

    AI/ML Overview

    The provided document is a 510(k) substantial equivalence determination letter from the FDA for Maxter Sterile Powder Free Latex Surgical Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this letter does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. These details would typically be found in the 510(k) submission itself or a separate study report, which is not provided here.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is essentially the FDA's approval notice, not the technical submission with performance data.

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