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510(k) Data Aggregation

    K Number
    K980605
    Device Name
    LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
    Manufacturer
    PT. SARANA INDOPROTEX
    Date Cleared
    1998-04-14

    (56 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 pation cxamination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Latex Patient Examination Gloves (Powder-Trade Name: Free) with Protein Content Labeling Claim (50 micrograms or less)

    AI/ML Overview

    Please provide the "Input" in the format specified by your request. The current input is malformed, with page numbers and descriptive text mixed with the content. I need a clear, contiguous block of text for analysis.

    Once formatted correctly, I will be able to extract the requested information about acceptance criteria and the study proving device conformance.

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