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510(k) Data Aggregation

    K Number
    K230135
    Device Name
    Copioumed Chemotherapy Isolation Gown
    Manufacturer
    Copioumed International Inc.
    Date Cleared
    2023-10-04

    (259 days)

    Product Code
    FYC, QSO
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Copioumed International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Copioumed Chemotherapy Isolation Gown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate. Copioumed Chemotherapy Isolation Gown is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. The Copioumed Chemotherapy Isolation Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-20 "Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact." Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes. *: Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etoposide [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 *No permeation was detected at either the minimum detectable permeation or 0.1 ug/cm2/min
    Device Description
    Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling, and administration. This device is non-sterile and for single use only. Copioumed Chemotherapy Isolation Gown is a Polypropylene Gown laminated with Polyethylene and Knit cuff in three styles: Tie neck closure, Velcro neck closure and Sticker neck closure.
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