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

    POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM

    K Number: K023912 · Decision Feb 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    78

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    Basic Information

    Device Name
    POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM
    K Number
    K023912
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sanrea Healthcare Private Limited
    Date Received
    November 25, 2002
    Decision Date
    February 11, 2003
    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 Sanrea Healthcare Private Limited

    K Number Device Name
    K023910 STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES
    K023915 STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES
    K023515 PRE-POWDERED LATEX SURGEON'S GLOVES