BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: N80535 · Supplement: S009 · Decision Jul 16, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ABSORBO HP-ABSORBABLE DUSTING POWDER
    PMA Number
    N80535
    Supplement Number
    S009
    Product Code
    KGP
    Generic Name
    Powder, dusting, surgical
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 16, 1999
    Date Received
    March 19, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revised labeling. The request to replace the warning statement: "WARNING-The Powder Should Be Washed Off Gloves with Sterile Solution Before Treated Gloves Are Used In Surgery," with the statement: "Caution: After donning, remove powder by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective method," is acceptable.