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510(k) Data Aggregation

    K Number
    K990527
    Device Name
    KLEENHANDS POWDERED LATEX EXAMINATION GLOVES
    Manufacturer
    SSN GLOVES (M) SDN BHD
    Date Cleared
    1999-04-23

    (63 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 MEDICAL OR A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE WORN QU THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN THE HEALTH CARE PERSONNEL AND THE PATIENT.

    Device Description

    Kleenhands Powdered Latex Examination Gloves

    AI/ML Overview

    The provided text is a letter from the FDA regarding the clearance of "Kleenhands Powdered Latex Examination Gloves" and an "Indications for Use" statement. It approves the marketing of the device but does not contain acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data or studies.

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