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

    GLOVES, FLOOR

    K Number: K780181 · Decision Feb 21, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    18

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    Basic Information

    Device Name
    GLOVES, FLOOR
    K Number
    K780181
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6140
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tillotson Rubber Co., Inc.
    Date Received
    February 3, 1978
    Decision Date
    February 21, 1978
    Product Code
    FML
    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
    FML Chair, Blood Donor

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    K Number Device Name
    K905765 PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES)
    K903756 STERILE PATIENT EXAMINATION GLOVES
    K903607 POWDER FREE, NON-STERILE EXAMINATION GLOVES
    K894828 HPI ORTHO SURGEONS' GLOVE
    K770704 GLOVES, SURGEONS, LATEX