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

    EXAM GLOVES (MFG. GUEY HER ENT. CO. LTD)

    K Number: K893025 · Decision Jan 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    286

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    Basic Information

    Device Name
    EXAM GLOVES (MFG. GUEY HER ENT. CO. LTD)
    K Number
    K893025
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Wen Hao, Inc.
    Date Received
    April 12, 1989
    Decision Date
    January 23, 1990
    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 Wen Hao, Inc.

    K Number Device Name
    K893027 PATIENT EXAM GLOVES (MFG JET FAR INDU. INC.)
    K885219 DENTAL DRESSING PLIERS
    K885217 DISCARD DENTAL EXPLORER
    K885218 DISCARD DENTAL MIRROR