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510(k) Data Aggregation

    K Number
    K983828
    Device Name
    NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE
    Manufacturer
    SINETIMED LATEX SDN BHD
    Date Cleared
    1999-01-21

    (83 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

    This glove is a disposable device intended for medical purpose that is worn on the hand of examiner to prevent contamination between patient and examiner.

    Device Description

    NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE

    AI/ML Overview

    This is a 510(k) premarket notification letter from the FDA to SinetiMed Latex Sdn. Bhd. for their NitriKleen-Nitrile Examination Glove Powder-Free surgical gloves. The letter states that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information on acceptance criteria, device performance, study details, or ground truth establishment. This is a regulatory clearance letter, not a study report. Therefore, I cannot extract the requested information from this document.

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