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    Reference Devices :

    K972615

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

    The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device Intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy Tested chemotherapy drugs are as follows [Cyclophosphamide, drugs. Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE

    Device Description

    Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein} meet all the requirements of ASTM standard D6978-05, D5712-054 and FDA 21 CFR 880.6250.

    AI/ML Overview

    The device, "Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein)," demonstrated compliance through a series of non-clinical performance studies. The studies assessed the gloves against various ASTM standards and internal performance criteria.

    1. Table of Acceptance Criteria and Reported Device Performance

    CHARACTERISTICSSTANDARDS / Acceptance CriteriaReported Device Performance
    DimensionsASTM D3578-01E1Meets
    Physical PropertiesASTM D3578-01E1Meets
    ThicknessASTM D3578-01E1Meets
    Powder FreeASTM D6124-01Meets (≤ 2 mg/glove)
    Protein LevelASTM D5712-95Meets (
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