BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GLOVES, VINYL EXAMINATION

    K Number: K781820 · Decision Dec 7, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    6
    Review Days
    41

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    Basic Information

    Device Name
    GLOVES, VINYL EXAMINATION
    K Number
    K781820
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Phoenix Glove Co.
    Date Received
    October 27, 1978
    Decision Date
    December 7, 1978
    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 Phoenix Glove Co.

    K Number Device Name
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    K821043 STERILE PATIENT EXAM. GLOVES
    K801846 ELECTROCARDIOGRAPH ELECTRODE