BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇳 India

    LATEX SURGICAL GLOVES, PRE-POWDERED

    K Number: K993450 · Decision Dec 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    LATEX SURGICAL GLOVES, PRE-POWDERED
    K Number
    K993450
    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
    Fitco Dipped Products Pvt., Ltd.
    Date Received
    October 12, 1999
    Decision Date
    December 29, 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 Fitco Dipped Products Pvt., Ltd.

    K Number Device Name
    K001715 POWDERED PATIENT EXAMINATION GLOVES, LATEX
    K001232 NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS
    K000896 POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS
    K001216 POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    K000891 STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES