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510(k) Data Aggregation

    K Number
    K171378
    Device Name
    Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
    Manufacturer
    SEMPERIT INVESTMENTS ASIA PTE. LTD.
    Date Cleared
    2017-09-14

    (127 days)

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

    SEMPERIT INVESTMENTS ASIA PTE. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes Vincristine Sulfate (1.0 mg/ml). Permeation time: no Breakthrough up to 240 minutes DO NOT USE WITH CARMUSTINE OR THIOTEPA
    Device Description
    The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs is provided in blue. It meets all the requirements of ASTM D6319-10. It is a medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves were tested for use with chemotherapy drugs per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
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    K Number
    K160781
    Device Name
    Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
    Manufacturer
    SEMPERIT INVESTMENTS ASIA PTE. LTD.
    Date Cleared
    2017-05-02

    (406 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEMPERIT INVESTMENTS ASIA PTE. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Powder Free Synthetic Rubber Gloves is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Sempermed Syntegra IR is a sterile powder-free surgeon glove. It is a disposable device made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. This glove is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
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