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

    ORTHOPEDIC SURGICAL GLOVE

    K Number: K831564 · Decision Jul 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    30
    Review Days
    57

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    Basic Information

    Device Name
    ORTHOPEDIC SURGICAL GLOVE
    K Number
    K831564
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ansell, Inc.
    Date Received
    May 16, 1983
    Decision Date
    July 12, 1983
    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 Ansell, Inc.

    K Number Device Name
    K984392 ANSELL CONDOMS
    K983518 LIFESTYLES XTRA PLEASURE
    K940047 SPERMICIDALLY LUBRICATED CONDOM
    K953379 HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE
    K945766 HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES
    K945767 POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES
    K940045 CONDOM
    K940046 NON-LUBRICATED CONDOM
    K913766 ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
    K914760 LATEX EXAMINATION GLOVES
    Search all 30 clearances from Ansell, Inc. →