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510(k) Data Aggregation

    K Number
    K031768
    Device Name
    BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-08-01

    (53 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED

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

    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Barrier-Pro™ Co-polymer Patient Examination Glove, Powdered, White (non-colored) or Green colored. Note: (a) Glove made from Synthetic Butadiene Methylmetacrylate Methacrylic Acid Co-polymer Rubber (b)Barrier-Pro™ is a registered trade mark of Dow Reichhold Specialty Latex LLC

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Barrier-Pro™ Co-Polymer Patient Examination Gloves." This document does not contain information about the acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets those criteria.

    Instead, this document is a regulatory approval for a physical medical device (patient examination gloves) based on substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set details) from this document as it pertains to a different type of medical device and regulatory review process.

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