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510(k) Data Aggregation

    K Number
    K222733
    Device Name
    Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
    Date Cleared
    2022-12-11

    (93 days)

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

    Inner Mongolia Boming Medical Supplies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes | |----------------------------|------------------------|----------------------------------------| | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.7 Minutes | | Cisplatin | 1.0 mg/ml(1,000 ppm) | 240 Minutes | | Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | 240 Minutes | | Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | 240 Minutes | | Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | 240 Minutes | | Etoposide | 20.0 mg/ml(20,000 ppm) | 240 Minutes | | Fluorouracil | 50.0 mg/ml(50,000 ppm) | 240 Minutes | | Methotrexate | 25 mg/ml(25,000 ppm) | 240 Minutes | | Mitomycin C | 0.5 mg/ml(500 ppm) | 240 Minutes | | Paclitaxel | 6.0 mg/ml(6,000 ppm) | 240 Minutes | | Thio Tepa | 10.0 mg/ml(10,000 ppm) | 45.7 Minutes | | Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | 240 Minutes | Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.7 Minutes Thio-Tepa 10.0 mg/ml 45.7 Minutes Caution: Testing showed an average breakthrough time of 45.7 minutes with Thio-Tepa WARNING: Do not use with Carmustine
    Device Description
    The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered non-sterile and in five sizes: extra-small, small, medium, large, and extra-large.
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    K Number
    K212467
    Device Name
    Disposable Nitrile Examination Glove
    Date Cleared
    2021-11-04

    (90 days)

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

    Inner Mongolia Boming Medical Supplies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free nitrile patient examination gloves. The subject device is blue color. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
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