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510(k) Data Aggregation

    K Number
    K244034
    Device Name
    Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
    Manufacturer
    Ever Global (Vietnam) Enterprise Corporation
    Date Cleared
    2025-02-06

    (38 days)

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

    Ever Global (Vietnam) Enterprise Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, and xylazine in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
    Device Description
    "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.
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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?
    Applicant Name (Manufacturer) :

    Ever Global (Vietnam) Enterprise Corporation

    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?
    Applicant Name (Manufacturer) :

    Ever Global (Vietnam) Enterprise Corporation

    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
    K190403
    Device Name
    Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
    Manufacturer
    Ever Global (Vietnam) Enterprise Corporation
    Date Cleared
    2019-09-06

    (199 days)

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

    Ever Global (Vietnam) Enterprise Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile 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 D6319-10, Standard specification for Nitrile Examination Gloves.
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