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

    POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM

    K Number: K030445 · Decision Jun 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    114

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    Basic Information

    Device Name
    POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM
    K Number
    K030445
    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
    K030444 PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES
    K021065 PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
    K020044 VINYL EXAMINATION GLOVES STERILE POWEDERED