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510(k) Data Aggregation

    K Number
    K211434
    Device Name
    Nitrile Patient Examination Gloves
    Date Cleared
    2021-08-05

    (87 days)

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

    Zhangjiagang Huayuan Protective Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free nitrile examination gloves. The glove is manufactured from nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. The subject device is blue. The subject device is non-sterile, and single use device to prevent contamination between patient and examiner. The subject device can be available in six specifications: XS、S、M、L、XL and XXL.
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