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

    PATIENT EXAINATION GLOVES

    K Number: K945045 · Decision Jan 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    11
    Review Days
    80

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    Basic Information

    Device Name
    PATIENT EXAINATION GLOVES
    K Number
    K945045
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Phoenix Medical Technology, Inc.
    Date Received
    October 14, 1994
    Decision Date
    January 2, 1995
    Product Code
    LYY
    Advisory Committee
    General Hospital
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Phoenix Medical Technology, Inc.

    K Number Device Name
    K000223 NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
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    K900453 MODIFIED SINGLE USE LATEX EXAMINATION GLOVES
    K900454 MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES
    K890917 PHOENIX DRAPES WITH MICROBAN
    K892976 SINGLE USE VINYL EXAM GLOVES - COLOR CODED
    K892975 LOW POWDER SINGLE USE LATEX EXAM GLOVES
    K891949 PATIENT EXAMINATION GLOVES (LATEX)
    K891132 PATIENT EXAMINATION GLOVE
    K853993 DOBE (MODIFIED)
    Search all 11 clearances from Phoenix Medical Technology, Inc. →