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510(k) Data Aggregation

    K Number
    K033777
    Device Name
    ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2004-02-05

    (63 days)

    Product Code
    LZA
    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 glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Ultrasense AF Blue Power-free Nitrile Examination Gloves

    AI/ML Overview

    This document pertains to the clearance of "Ultrasense AF Blue Power-Free Nitrile Examination Gloves" (K033777). As such, it is a device submission for a physical product (gloves), not a diagnostic AI/ML algorithm or software as a medical device (SaMD).

    Therefore, the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and sample sizes for an AI/ML device is not applicable to this document.

    The document discusses the substantial equivalence determination for examination gloves based on regulatory requirements for a physical medical device, not a software-based diagnostic tool.

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