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510(k) Data Aggregation

    K Number
    K991939
    Device Name
    BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
    Manufacturer
    BRIGHTWAY HOLDINGS SDN. BHD.
    Date Cleared
    1999-07-01

    (22 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 Nitrile Surgical Glove - Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worry by operating room personnel to protect a surgical wound from contamination.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "BRIGHTWAY® Brand Nitrile Surgical Gloves - Sterile (Powder-Free)". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

    The document is a regulatory approval letter, indicating that the device is substantially equivalent to a legally marketed predicate device. This type of document typically references the safety and performance of the device against established standards or predicate devices, but it does not detail the specific acceptance criteria or the study data used to demonstrate compliance in the way a clinical study report or a detailed test report would.

    Therefore, I cannot provide the requested information from the given text. The text does not elaborate on:

    1. A table of acceptance criteria and the reported device performance: This information is not present. The letter only states that the device is "substantially equivalent."
    2. Sample size for the test set and data provenance: Not mentioned.
    3. Number of experts used to establish ground truth and qualifications: Not mentioned.
    4. Adjudication method for the test set: Not mentioned.
    5. MRMC comparative effectiveness study: Not mentioned.
    6. Standalone performance study: Not mentioned.
    7. Type of ground truth used: Not mentioned.
    8. Sample size for the training set: Not applicable as this is a medical device, not an AI/ML algorithm.
    9. How ground truth for the training set was established: Not applicable.
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