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

    STERILE DISPOSABLE SURGICAL GLOVES

    K Number: K830635 · Decision Jan 30, 1984
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    335

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    STERILE DISPOSABLE SURGICAL GLOVES
    K Number
    K830635
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Intermarket Latex, Inc.
    Date Received
    March 1, 1983
    Decision Date
    January 30, 1984
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Other Clearances by Intermarket Latex, Inc.

    K Number Device Name
    K812421 STERILE DISPOSABLE SURGICAL GLOVES