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510(k) Data Aggregation

    K Number
    K090336
    Device Name
    SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
    Manufacturer
    SUNMAX ENTERPRISE SHANGHAI CO. LTD.
    Date Cleared
    2009-07-01

    (141 days)

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

    SUNMAX ENTERPRISE SHANGHAI CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.
    Device Description
    Sunmax Enterprise Shanghai Co Powder free blue Nitrile Examination Glove is a class II device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.
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    K Number
    K011765
    Device Name
    SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
    Manufacturer
    SUNMAX ENTERPRISE SHANGHAI CO. LTD.
    Date Cleared
    2001-08-16

    (70 days)

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

    SUNMAX ENTERPRISE SHANGHAI CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powderfree patient examination glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Sunmax Blue Nitrile Powderfree Examination Glove
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    K Number
    K011717
    Device Name
    SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
    Manufacturer
    SUNMAX ENTERPRISE SHANGHAI CO. LTD.
    Date Cleared
    2001-08-14

    (71 days)

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

    SUNMAX ENTERPRISE SHANGHAI CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powdered patient examination glove is a disposable device made of nitrile for medical purposes that is worn upon the hand to prevent contamination between patient and examiner.
    Device Description
    Sunmax Blue Nitrile Powdered Examination Gloves
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    K Number
    K964964
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SUNMAX ENTERPRISE SHANGHAI CO. LTD.
    Date Cleared
    1997-02-07

    (58 days)

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

    SUNMAX ENTERPRISE SHANGHAI CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960746
    Device Name
    SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES
    Manufacturer
    SUNMAX ENTERPRISE SHANGHAI CO. LTD.
    Date Cleared
    1996-06-27

    (125 days)

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

    SUNMAX ENTERPRISE SHANGHAI CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel the patient's body, and fluids, waste or environment.
    Device Description
    Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
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