Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162381
    Device Name
    HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
    Date Cleared
    2017-01-31

    (160 days)

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

    HEALTHY GLOVE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drugs at specific concentrations as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The gloves have been tested with the following drugs and the respective breakthrough detection times are listed below. | No. | Chemotherapy Drugs and Concentrations | Breakthrough | |-----|---------------------------------------|---------------| | 1. | Blenoxane (15 mg/ml) | > 240 minutes | | 2. | Busulfan (6 mg/ml) | > 240 minutes | | 3. | Carboplatin (10 mg/ml) | > 240 minutes | | 4. | Carmustine (BCNU) (3.3 mg/ml)* | 30.4 minutes | | 5. | Cisplatin (1.0 mg/ml) | > 240 minutes | | 6. | Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes | | 7. | Cytarabine (100 mg/ml) | > 240 minutes | | 8. | Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes | | 9. | Daunorubicin (5 mg/ml) | > 240 minutes | | 10. | Docetaxel (10.0 mg/ml) | > 240 minutes | | 11. | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes | | 12. | Ellence (2 mg/ml) | > 240 minutes | | 13. | Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes | | 14. | Fludarabine (25 mg/ml) | > 240 minutes | | 15. | Fluorouracil (50.0 mg/ml) | > 240 minutes | | 16. | Ganciclovir (10 mg/ml) | > 240 minutes | | 17. | Gemcitabine (Gemzar) (38 mg/ml) | > 240 minutes | | 18. | Idarubicin (1 mg/ml) | > 240 minutes | | 19. | Ifosfamide (50.0 mg/ml) | > 240 minutes | | 20. | Irinotecan (20.0 mg/ml) | > 240 minutes | | 21. | Mechlorethamine HCl (1.0 mg/ml) | > 240 minutes | | 22. | Melphalan (5 mg/ml) | > 240 minutes | | 23. | Methotrexate (25 mg/ml) | > 240 minutes | | 24. | Mitoxantrone (2.0mg/ml) | > 240 minutes | | 25. | Mitomycin C (0.5 mg/ml) | > 240 minutes | | 26. | Oxaliplatin (5 mg/ml) | > 240 minutes | | 27. | Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes | | 28. | Rituximab (10 mg/ml) | > 240 minutes | | 29. | Thiotepa (10.0 mg/ml) | > 240 minutes | | 30. | Trisenox (0.1 mg/ml) | > 240 minutes | | 31. | Vincristine Sulfate (1.0 mg/ml) | > 240 minutes | | 32. | Vinorelbine (10 mg/ml) | > 240 minutes |
    Device Description
    Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs are non-sterile, lavender blue colored, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Chemotherapy drugs listed in the Intended Use(s) section below, as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1