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

    Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs

    K Number: K213325 · Decision Jan 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    2
    Review Days
    115

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    Basic Information

    Device Name
    Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
    K Number
    K213325
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Anhui Xinyisheng Medical Technology Co.,Ltd
    Date Received
    October 5, 2021
    Decision Date
    January 28, 2022
    Product Code
    LZC
    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
    LZC Medical Glove, Specialty

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    Other Clearances by Anhui Xinyisheng Medical Technology Co.,Ltd

    K Number Device Name
    K213371 Disposable Medical Nitrile Examination Gloves (Model:XYS-001)