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510(k) Data Aggregation

    K Number
    K030333
    Device Name
    LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN BHD
    Date Cleared
    2003-03-21

    (49 days)

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

    LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM

    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

    Latex Patient Examination Glove, Powdcred Type II, Low Modulus, with extractable protein content labelling claim (200 microgram per gram of glove or less)

    AI/ML Overview

    This document is a 510(k) clearance letter for "Latex Examination Gloves, Powdered Type II, Low Modulus with Extractable Protein Content Labeling Claim (200 Micrograms or Less)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain information about acceptance criteria, device performance studies, or ground truth establishment typically found in detailed device validation reports.

    The provided text focuses on the regulatory clearance process rather than technical performance data. Therefore, I cannot extract the requested information.

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