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510(k) Data Aggregation

    K Number
    K161929
    Device Name
    Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
    Date Cleared
    2017-03-29

    (258 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dipped Products (Thailand) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Palm-pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs. The following Chemotherapy drugs have been tested for use with these gloves in accordance with ASTM D6978-05: Chemotherapy drug (concentration) | Breakthrough Detection Time -----------------------------------|----------------------------------- Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes *Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes Etoposide (20,000 ppm) | No breakthrough up to 240 minutes Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes Thiotepa (10,000 ppm) | Breakthrough at 181.3 minutes *Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 30.6 minutes.
    Device Description
    The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs are patient examination gloves that worn by an examiner to prevent contamination between the patient and examiner. The gloves are suitable for use with Chemotherapy drugs, are ambidextrous and green in color. The gloves are supplied non-sterile, in boxes of 100 (measured by weight), intended for single use and are disposable.
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