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Found 4 results

510(k) Data Aggregation

    K Number
    K213373
    Device Name
    Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    Smart Glove Corporation Sdn.Bhd.
    Date Cleared
    2022-03-10

    (149 days)

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

    Smart Glove Corporation Sdn.Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. The gloves were tested with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
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    K Number
    K181047
    Device Name
    Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
    Manufacturer
    Smart Glove Corporation Sdn.Bhd.
    Date Cleared
    2019-01-09

    (265 days)

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

    Smart Glove Corporation Sdn.Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent containation between patient and examiner. Tested for use with chemotherapy drugs as listed below.
    Device Description
    Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
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    K Number
    K180221
    Device Name
    Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs
    Manufacturer
    Smart Glove Corporation Sdn.Bhd
    Date Cleared
    2018-08-08

    (195 days)

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

    Smart Glove Corporation Sdn.Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contained a a aspossors and examiner. Tested for use with chemotherapy drugs as listed below.
    Device Description
    Powder Free White , Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
    Ask a Question
    K Number
    K171743
    Device Name
    Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves
    Manufacturer
    Smart Glove Corporation Sdn.Bhd
    Date Cleared
    2017-11-17

    (158 days)

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

    Smart Glove Corporation Sdn.Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Not Found
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