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510(k) Data Aggregation

    K Number
    K210463
    Device Name
    Thermoplastic Elastomer (TPE) Hybrid Examination Glove
    Date Cleared
    2022-01-23

    (341 days)

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

    Xuzhou Full Sun Medical Products Ltd.

    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
    Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a patient examination glove made from polyethylene resin and styrene-ethylene-styrene (SEBS) compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K111240
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
    Date Cleared
    2011-07-14

    (72 days)

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

    XUZHOU FULL SUN MEDICAL PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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 vinyl patient examination gloves, non sterile that meets all of the requirements of ASTM --standard-D-5250-06
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    K Number
    K072377
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR
    Date Cleared
    2007-12-14

    (112 days)

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

    XUZHOU FULL SUN MEDICAL PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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
    Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
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    K Number
    K071122
    Device Name
    DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR
    Date Cleared
    2007-12-12

    (233 days)

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

    XUZHOU FULL SUN MEDICAL PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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
    Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 801.VZ, and meets all requirements of ASTM Standard D5250-06
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    K Number
    K072314
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
    Date Cleared
    2007-12-12

    (117 days)

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

    XUZHOU FULL SUN MEDICAL PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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
    Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
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    K Number
    K072472
    Device Name
    DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
    Date Cleared
    2007-10-25

    (51 days)

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

    XUZHOU FULL SUN MEDICAL PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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
    Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06
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    K Number
    K072401
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
    Date Cleared
    2007-10-15

    (49 days)

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

    XUZHOU FULL SUN MEDICAL PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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
    Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
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    K Number
    K071123
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
    Date Cleared
    2007-07-30

    (98 days)

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

    XUZHOU FULL SUN MEDICAL PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVES 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
    Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
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