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

    POWDER FREE NITRILE GLOVE

    K Number: K922116 · Decision Feb 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    6
    Review Days
    333

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    Basic Information

    Device Name
    POWDER FREE NITRILE GLOVE
    K Number
    K922116
    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
    Hpi, Inc.
    Date Received
    March 12, 1992
    Decision Date
    February 8, 1993
    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 Hpi, Inc.

    K Number Device Name
    K915086 HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES
    K910383 HPI SENSI-SHIELD GLOVE KIT
    K904878 SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
    K905086 HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
    K901608 HPI POWDER FREE NON-STERILE EXAMINATION GLOVES