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510(k) Data Aggregation

    K Number
    K022090
    Device Name
    SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2002-09-03

    (68 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

    Device Description

    Pre-Powdered Nitirile Examination Glove

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The text provided is an FDA clearance letter for a medical device (Syntex Pre-Powdered Nitrile Examination Glove), outlining its substantial equivalence to a predicate device and regulatory compliance. It does not contain details about specific performance metrics or studies.

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