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510(k) Data Aggregation

    K Number
    K992021
    Device Name
    BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)
    Manufacturer
    BRIGHTSWAY HOLDINGS SDN BHD
    Date Cleared
    1999-07-23

    (37 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

    BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) containing 50 µgm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    BRIGHTWAY™ Brand Latex Surgical Gloves - Sterile (Powder Free) Containing 50 ugm or less of water Extractable protein per gram.

    AI/ML Overview

    This letter is a 510(k) clearance for "Brightway™ Brand Latex Surgical Gloves - Sterile (Powder Free)". It indicates the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain any information regarding specific acceptance criteria, study details, or performance data for the gloves.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the provided document.

    The document is a regulatory approval letter, which confirms the device can be marketed based on its substantial equivalence to another device, but it does not detail the technical performance studies.

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