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

    PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.)

    K Number: K892100 · Decision May 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    35

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    Basic Information

    Device Name
    PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.)
    K Number
    K892100
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ergo Intl., Ent., Inc.
    Date Received
    April 3, 1989
    Decision Date
    May 8, 1989
    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 Ergo Intl., Ent., Inc.

    K Number Device Name
    K892166 NON-STERILE PATIENT EXAM GLOVES (LATEX)
    K892026 PROLAX PATIENT EXAMINATION GLOVES (LATEX)
    K892101 PATIENT EXAM GLOVES (MFG. SHUN TAHI RUBBER GLOVES)
    K884030 ERGO II, SURGICAL LATEX GLOVES