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510(k) Data Aggregation

    K Number
    K984311
    Device Name
    NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE
    Manufacturer
    SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD.
    Date Cleared
    1999-02-09

    (69 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A medical glove is worn on the hand of the health care and similar personnel to Prevent contamination between the personnel and the patient being treated.

    Device Description

    NBR 4 Mils Nitrile Powder Free Examination Gloves Non-Sterile

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for NBR 4 Mils Nitrile Powder-Free Examination Gloves. It details the FDA's decision regarding the substantial equivalence of the device.

    However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter acknowledges the submission and clarifies regulatory aspects but does not include technical performance data, test results, or study details.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, rather than detailed performance and study data.

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