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

    LATEX SURGEON GLOVES

    K Number: K901398 · Decision May 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    14
    Review Days
    51

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    Basic Information

    Device Name
    LATEX SURGEON GLOVES
    K Number
    K901398
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sinochem (Usa), Inc.
    Date Received
    March 26, 1990
    Decision Date
    May 16, 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 Sinochem (Usa), Inc.

    K Number Device Name
    K900980 LATEX EXAMINATION GLOVES
    K900352 LATEX EXAM GLOVES (SHANGHAI RONGTONG LATEX GLOVES)
    K893882 LATEX EXAMINATION GLOVES
    K893694 LATEX EXAM GLOVES(MFG: SHANG HAI RONGTONG LATEX)
    K892154 PATIENT EXAM GLOVES (MFG. LIAONING FOREIGN TRADE)
    K892158 PATIENT EXAM GLOVES (MFG. SUZHOU LATEX FACTORY)
    K892153 PATIENT EXAM GLOVES (MFG. JIANDE RUBBER PRODUCTS)
    K892156 PATIENT EXAM GLOVES (MFG. NO. 1 FACTORY, WUHAN)
    K892151 PATIENT EXAM GLOVES (MFG. GUILIN LATEX FACTORY)
    K892155 PATIENT EXAM GLOVES (MFG. HUBEI TIANMEN LATEX)
    Search all 14 clearances from Sinochem (Usa), Inc. →