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510(k) Data Aggregation

    K Number
    K242812
    Device Name
    NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
    Date Cleared
    2024-10-12

    (24 days)

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

    NB MEDICAL COMPANY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device. Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml) The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes Warning: Not for Use with: Carmustine, ThioTEPA
    Device Description
    NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per D6978-05(2023). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) are offered in different sizes: S/M/L/XL.
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