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510(k) Data Aggregation

    K Number
    K201774
    Device Name
    Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs
    Date Cleared
    2020-09-16

    (79 days)

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

    PT. Medisafe Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
    Device Description
    Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatius Potential and Tested for Use with Chemotherapy Drugs
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    K Number
    K182176
    Device Name
    Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
    Date Cleared
    2019-03-28

    (230 days)

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

    PT. Medisafe Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
    Device Description
    Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
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    K Number
    K173258
    Device Name
    Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
    Date Cleared
    2018-04-20

    (192 days)

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

    Pt. Medisafe Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
    Device Description
    This surgeon's glove is a device made of synthetic rubber.
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    K Number
    K163041
    Device Name
    Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
    Date Cleared
    2017-02-22

    (114 days)

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

    PT. MEDISAFE TECHNOLOGIES

    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 hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder Free Polychloroprene Examination Gloves - Pink with Aloe Vera and Vitamin E
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    K Number
    K133689
    Device Name
    POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
    Date Cleared
    2014-07-03

    (213 days)

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

    PT. MEDISAFE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
    Device Description
    Powder Free Polychloroprene Light Weight Examination Gloves-Green, Blue and Pink
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    K Number
    K112654
    Device Name
    POWDERFREE POLYISOPRENE SURGICAL GLOVES
    Date Cleared
    2012-02-17

    (158 days)

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

    PT. MEDISAFE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This surgeon's glove is a device made of Synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Powder Free White Sterile Polyisoprene Surgical Gloves
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    K Number
    K102623
    Device Name
    BLUE POWDERFREE NITRILE EXAMINATION GLOVE
    Date Cleared
    2011-06-06

    (266 days)

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

    PT. MEDISAFE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below.
    Device Description
    Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.
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    K Number
    K102620
    Device Name
    POWDERFREE BLACK NITRILE EXAMINATION GLOVES
    Date Cleared
    2010-11-22

    (70 days)

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

    PT. MEDISAFE TECHNOLOGIES

    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 hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder Free Black Nitrile Examination Gloves
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    K Number
    K082302
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
    Date Cleared
    2008-12-09

    (119 days)

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

    PT. MEDISAFE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below: - Carmustine (BiCNU); - Cyclophosphamide; - Doxorubicin Hydrochloride; - 5-Fluorouracil; - Cisplatin; - Etoposide; - Paclitaxel: - Thio-Tepa - Dacarbazine
    Device Description
    The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below: - Carmustine (BiCNU); - Cyclophosphamide; - Doxorubicin Hydrochloride; - 5-Fluorouracil; - Cisplatin; - Etoposide; - Paclitaxel: - Thio-Tepa - Dacarbazine
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    K Number
    K050968
    Device Name
    POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
    Date Cleared
    2005-07-12

    (85 days)

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

    PT. MEDISAFE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a disposable synthetic rubber examination glove intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner.
    Device Description
    Not Found
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