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

    PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES)

    K Number: K905765 · Decision Feb 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    60

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    Basic Information

    Device Name
    PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES)
    K Number
    K905765
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tillotson Rubber Co., Inc.
    Date Received
    December 27, 1990
    Decision Date
    February 25, 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 Tillotson Rubber Co., Inc.

    K Number Device Name
    K903756 STERILE PATIENT EXAMINATION GLOVES
    K903607 POWDER FREE, NON-STERILE EXAMINATION GLOVES
    K894828 HPI ORTHO SURGEONS' GLOVE
    K780181 GLOVES, FLOOR
    K770704 GLOVES, SURGEONS, LATEX