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

    PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES

    K Number: K030444 · Decision Jun 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    4
    Review Days
    114

    Basic Information

    Device Name
    PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES
    K Number
    K030444
    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
    PRIMUS GLOVES PRIVATE LTD.
    Date Received
    February 11, 2003
    Decision Date
    June 5, 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 PRIMUS GLOVES PRIVATE LTD.

    K Number Device Name
    K030445 POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM
    K021065 PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
    K020044 VINYL EXAMINATION GLOVES STERILE POWEDERED