BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇸🇬 Singapore

    Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves

    K Number: K160781 · Decision May 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    406

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    Basic Information

    Device Name
    Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
    K Number
    K160781
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Semperit Investments Asia Pte , Ltd.
    Date Received
    March 22, 2016
    Decision Date
    May 2, 2017
    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 Semperit Investments Asia Pte , Ltd.

    K Number Device Name
    K223903 Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)
    K183441 Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
    K171378 Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs