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510(k) Data Aggregation

    K Number
    K974184
    Device Name
    HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)
    Manufacturer
    SRI JOHANI SDN. BHD.
    Date Cleared
    1997-12-18

    (42 days)

    Product Code
    LYY
    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 for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Safety Powderfree Blue Latex Examination Gloves (Polymer Coated)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Therefore, I cannot provide the requested information based on the provided text.

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