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510(k) Data Aggregation

    K Number
    K990575
    Device Name
    TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
    Manufacturer
    TA CHIA RUBBER IND. CORP.
    Date Cleared
    1999-05-04

    (70 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 patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powdered Non-Sterile Nitrile Examination Gloves

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Powdered Non-Sterile Nitrile Examination Gloves" manufactured by TA CHIA RUBBER IND. CORP. LTD.

    It does not describe any acceptance criteria or a study that proves the device meets acceptance criteria. The letter simply states that the FDA has reviewed the 510(k) application and determined the device is "substantially equivalent" to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the provided text. The document is an administrative clearance, not a study report or a description of performance criteria.

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