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

    ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    K Number: K991205 · Decision Oct 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    63
    Review Days
    187

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    Basic Information

    Device Name
    ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K Number
    K991205
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allegiance Healthcare Corp.
    Date Received
    April 9, 1999
    Decision Date
    October 13, 1999
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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    Other Clearances by Allegiance Healthcare Corp.

    K Number Device Name
    K023673 AIRLIFE DEMAND NASAL CANNULA
    K023419 TRILAMINATE DRAPES/TIBURON
    K024120 MODIFICATION TO TEMNO BIOPSY NEEDLES
    K024292 MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
    K024102 DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
    K023425 DRAPES WITH ABSORBENT REINFORCEMENT
    K022765 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023170 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023167 BREATHABLE SURGICAL GOWN
    K012931 GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
    Search all 63 clearances from Allegiance Healthcare Corp. →