BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Single-Use Latex Sterile Surgical Gloves (SG100)

    K Number: K231446 · Decision Sep 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    4
    Review Days
    127

    Basic Information

    Device Name
    Single-Use Latex Sterile Surgical Gloves (SG100)
    K Number
    K231446
    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
    Fitone Latex Products Co., Ltd. Guangdong
    Date Received
    May 18, 2023
    Decision Date
    September 22, 2023
    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 Fitone Latex Products Co., Ltd. Guangdong

    K Number Device Name
    K221747 Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
    K222693 Single-use medical latex examination gloves (LG100)
    K211927 Nitrile examination gloves