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

    ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)

    K Number: K984559 · Decision Feb 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    22
    Review Days
    65

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    Basic Information

    Device Name
    ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
    K Number
    K984559
    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
    Ansell Perry
    Date Received
    December 23, 1998
    Decision Date
    February 26, 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 Ansell Perry

    K Number Device Name
    K003895 X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21
    K002192 DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38
    K001239 ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K000165 NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
    K000295 ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K993857 THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR
    K992953 SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM
    K992156 SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
    K992768 NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
    K984558 DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
    Search all 22 clearances from Ansell Perry →