BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Disposable Vinyl Nitrile Synthetic Gloves Powder Free

    K Number: K211516 · Decision Aug 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    5
    Review Days
    99

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    Basic Information

    Device Name
    Disposable Vinyl Nitrile Synthetic Gloves Powder Free
    K Number
    K211516
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tangshan Hongyun Plastic Products Co., Ltd.
    Date Received
    May 17, 2021
    Decision Date
    August 24, 2021
    Product Code
    LYZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYZ Vinyl Patient Examination Glove

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    Other Clearances by Tangshan Hongyun Plastic Products Co., Ltd.

    K Number Device Name
    K141878 HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
    K142343 Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored)
    K071999 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    K072001 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)