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510(k) Data Aggregation

    K Number
    K991940
    Device Name
    BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)
    Manufacturer
    BRIGHTWAY HOLDINGS SDN. BHD.
    Date Cleared
    1999-07-12

    (33 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 Gloves - Sterile (Powdered) is intended to be worn by a ulsposable glove made or by a protect a surgical wound from contamination.

    Device Description

    BRIGHTWAY™ Brand Nitrile Surgical Gloves - Sterile (Powdered)

    AI/ML Overview

    This looks like a 510(k) clearance letter for Nitrile Surgical Gloves. The provided text does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or ground truth establishment relevant to the request. This document is a regulatory approval letter, not a study report.

    Therefore, I cannot answer the questions based on the provided input.

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