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510(k) Data Aggregation

    K Number
    K993454
    Device Name
    POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
    Manufacturer
    SRI JOHANI SDN. BHD.
    Date Cleared
    1999-12-03

    (51 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

    Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves (Polymer Coated)". This document does not contain any information about acceptance criteria, device performance studies, or details regarding AI systems.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input, as this information is not present in the document.

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