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510(k) Data Aggregation

    K Number
    K992678
    Device Name
    PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
    Manufacturer
    WEAR SAFE MALAYSIA SDN. BHD.
    Date Cleared
    1999-11-17

    (99 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 :

    PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED

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

    A patient Examination Powder-Free Chlorinated 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

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the required information to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for a Nitrile Patient Examination Glove, Powder-Free, and outlines the regulatory classification and compliance, but does not detail the specific performance acceptance criteria or the studies conducted. Therefore, I cannot generate the requested table and accompanying details.

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