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

    PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF

    K Number: K914628 · Decision Nov 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    7
    Review Days
    86

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    Basic Information

    Device Name
    PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF
    K Number
    K914628
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Resources, Ltd.
    Date Received
    August 13, 1991
    Decision Date
    November 7, 1991
    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 Medical Resources, Ltd.

    K Number Device Name
    K931250 PHYNE-TOUCH PF
    K903559 HIGH RISK
    K895195 CHEMO-TOUCH
    K894212 PHYNE-TOUCH-STERILE
    K885096 PHYNE-VU
    K890983 PHYNE-TOUCH (PATIENT EXAMINATION GLOVES)