BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    NON-STERILE VINYL GLOVES

    K Number: K885346 · Decision Jan 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    NON-STERILE VINYL GLOVES
    K Number
    K885346
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Daw Shin Industrial Co., Ltd.
    Date Received
    December 28, 1988
    Decision Date
    January 18, 1989
    Product Code
    FMC
    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
    FMC Patient Examination Glove

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    Other Clearances by Daw Shin Industrial Co., Ltd.

    K Number Device Name
    K890851 PATIENT EXAMINATION GLOVES (NON-STERILE VINYL)