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510(k) Data Aggregation

    K Number
    K974183
    Device Name
    POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
    Manufacturer
    SRI JOHANI SDN. BHD.
    Date Cleared
    1997-12-18

    (42 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 Patient Examination Glove is a disposable device intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Pouderfree Blue Nitrile Examination Gloves Polymer Coated

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Powderfree Blue Nitrile Examination Gloves (Polymer Coated)". It states that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as requested in your prompt. This type of regulatory clearance letter typically confirms substantial equivalence based on comparisons to existing devices, and often refers to supporting data previously submitted, but does not present the study details itself.

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