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

    Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

    K Number: K181130 · Decision Aug 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    7
    Review Days
    102

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    Basic Information

    Device Name
    Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
    K Number
    K181130
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hebei Titans Hongsen Medical Technology Co., Ltd.
    Date Received
    April 30, 2018
    Decision Date
    August 10, 2018
    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 Hebei Titans Hongsen Medical Technology Co., Ltd.

    K Number Device Name
    K240361 Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)
    K223895 Disposable Medical Nitrile Examination Gloves
    K221374 Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
    K212097 Disposable medical surgical mask
    K211229 Vinyl compound examination gloves
    K182043 Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)