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510(k) Data Aggregation

    K Number
    K981164
    Device Name
    POWDER FREE CHLORINATED GLOVES-(TEXTURED)
    Manufacturer
    PAN-CENTURY RUBBER PRODUCTS SDN. BHD.
    Date Cleared
    1998-04-23

    (23 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 DISPOSAL DEVICE TO PREVENT CONTAMINATION BETWEEN THE PATIENT AND EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN THE PATIENT AND EXAMINER .

    Device Description

    POWDER FREE ( TEXTURED ) LATEX EXAMINATION GLOVES ATTH PROTETH LABELLING CLAIMS ( 50 MICROGRAMS OR LESS )

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." It is a regulatory approval document and does not contain the information requested regarding acceptance criteria or a study proving device performance in the context of an AI/medical device study.

    Therefore, I cannot provide the requested information from the given text.

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