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510(k) Data Aggregation

    K Number
    K241252
    Device Name
    Disposable Vinyl Examination Gloves
    Manufacturer
    Anqing Pukang Medical Technology Co., LTD.
    Date Cleared
    2024-05-20

    (17 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Vinyl Examination Gloves 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
    The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5
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    K Number
    K230046
    Device Name
    Vinyl examination gloves
    Manufacturer
    Guangdong Kingfa Sci.& Tech.Co., Ltd.
    Date Cleared
    2023-03-25

    (78 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.
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    K Number
    K221980
    Device Name
    Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
    Manufacturer
    Ever Global (Vietnam) Enterprise Corporation
    Date Cleared
    2023-02-06

    (216 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A non-powdered 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
    A Disposable Powder Free Vinyl Examination Gloves (with color Beige or Clear) is a patient examination glove made from poly (vinvl chloride), non-sterile (as per 21 CFR 880.6250, Class I). The operation principle of this medical device is 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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
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    K Number
    K220992
    Device Name
    Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
    Manufacturer
    Ever Global (Vietnam) Enterprise Corporation
    Date Cleared
    2022-10-19

    (198 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A non-powdered 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
    A Disposable Powder Free Vinyl Exam Glove (with color Black, Blue, or Purple) is a patient examination glove made from poly (vinyl chloride), non-sterile (as per 21 CFR 880.6250, Class I). This device is available in size S, M, L, and XL. The operation principle of this medical device is 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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
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    K Number
    K223008
    Device Name
    Disposable Vinyl Examination Gloves
    Manufacturer
    Jiangxi Handspro Products Solutions CO., LTD.
    Date Cleared
    2022-10-08

    (9 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
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    K Number
    K222442
    Device Name
    DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
    Manufacturer
    Anhui Bytech Medical Supplies Co., Ltd.
    Date Cleared
    2022-09-28

    (47 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free vinyl examination glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
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    K Number
    K220055
    Device Name
    Disposable, vinyl examination gloves, Yellow
    Manufacturer
    Dezhou Hengchang Medical Technology Co., Ltd
    Date Cleared
    2022-08-25

    (231 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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    K Number
    K220469
    Device Name
    Disposable Vinyl Examination Glove
    Manufacturer
    Chifeng Huawei Medical Science&Technology Co.,Ltd.
    Date Cleared
    2022-06-16

    (118 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DISPOSABLE VINYL EXAMINATION GLOVE is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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    K Number
    K220240
    Device Name
    Vinyl Co-Polymer Powder-free Examination Gloves, Black
    Manufacturer
    Grand Work Plastic Products Co., Ltd
    Date Cleared
    2022-03-31

    (62 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vinyl Co-Polymer Powder-free Examination Gloves, Black is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Vinyl Co-Polymer Powder-free Examination Gloves, Black are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Vinyl Examination Gloves for Medical Application.
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    K Number
    K213634
    Device Name
    Vinyl/Nitrile Blend Exam Glove
    Manufacturer
    Dezhou Hengchang Medical Technology Co., Ltd.
    Date Cleared
    2022-02-18

    (93 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    LYZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Viny/Nitrile Blend Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free vinyl/nitrile blend examination gloves. The subject device is blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
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