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510(k) Data Aggregation

    K Number
    K220859
    Device Name
    Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
    Manufacturer
    Careglove Global SDN BHD
    Date Cleared
    2022-09-09

    (169 days)

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

    Careglove Global SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K213993
    Device Name
    Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
    Manufacturer
    Careglove Global SDN BHD
    Date Cleared
    2022-08-05

    (227 days)

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

    Careglove Global 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
    It is a powder-free chloroprene patient examination gloves made by on-line polymer-coating and mild on-line chlorination process. The process modifies the surface characteristics without the use of any dusting or donning powder. The gloves are non-sterile, disposable and for single use only. Characteristics: - Ambidextrous with beaded cuff - Blended synthetic latex (Chloroprene and Nitrile Latex) - Blue or green Coloured ● - Five sizes: X-Small, Small, Medium, Large and X-Large. ●
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    K Number
    K190241
    Device Name
    Sterile Latex Surgical Glove, Powder Free
    Manufacturer
    Careglove Global Sdn Bhd
    Date Cleared
    2019-12-30

    (327 days)

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

    Careglove Global Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The subject device is a powder-free variation of the class I latex surgical gloves made by on-line polymercoating process. This process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
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    K Number
    K172015
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
    Manufacturer
    Careglove Global Sdn Bhd
    Date Cleared
    2017-09-26

    (85 days)

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

    Careglove Global 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
    It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tackfree without the use of any dusting or donning powder.
    Ask a Question
    K Number
    K161833
    Device Name
    LATEX EXAMINATION GLOVE POWDER FREE
    Manufacturer
    CAREGLOVE GLOBAL SDN BHD
    Date Cleared
    2017-05-23

    (322 days)

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

    CAREGLOVE GLOBAL 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
    It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
    Ask a Question

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