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

    GLOVES, PROCEDURE

    K Number: K781278 · Decision Aug 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    37

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    Basic Information

    Device Name
    GLOVES, PROCEDURE
    K Number
    K781278
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Arbrook Mfg. Corp.
    Date Received
    July 25, 1978
    Decision Date
    August 31, 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 Arbrook Mfg. Corp.

    K Number Device Name
    K792016 DISCARD-A-PAD 40-COUNT SHARPS DISPOSAL
    K781847 LATEX, IN-HOUSE COMPOUNDED
    K770056 GLOVES, SURGEONS,MICRO-TOUCH POWDERFREE
    K760421 THERMOMETER, SURVALENT-ELECTRONIC