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510(k) Data Aggregation

    K Number
    K993457
    Device Name
    POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]
    Manufacturer
    SRI JOHANI SDN. BHD.
    Date Cleared
    1999-12-02

    (50 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 pervent contamination between patient and examiner.

    Device Description

    Powderfree Latex Examination Gloves (Protein Label Claim) C 50mcg of

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for "Powderfree Latex Examination Gloves (Protein Trade Name: Label Claim)." It is not a study that evaluates a medical device against acceptance criteria using performance data. Therefore, I cannot extract the requested information.

    The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. It does not contain any details about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

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