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

    STERILE LATEX SURGICAL GLOVE

    K Number: K892899 · Decision Jan 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    272

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    Basic Information

    Device Name
    STERILE LATEX SURGICAL GLOVE
    K Number
    K892899
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tomarc (M) Sdn Bhd
    Date Received
    April 20, 1989
    Decision Date
    January 17, 1990
    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 Tomarc (M) Sdn Bhd

    K Number Device Name
    K931633 POWDER-FREE LATEX PATIENT EXAMINATION GLOVES
    K923589 STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV
    K890440 LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER)
    K890344 GLOVES, PATIENT EXAMINATION