BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ACTIPROTECT UC N95 RESPIRATOR

    K Number: K093189 · Decision Jul 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    266

    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
    ACTIPROTECT UC N95 RESPIRATOR
    K Number
    K093189
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.6260
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glaxosmithkline Consumer Healthcare
    Date Received
    October 9, 2009
    Decision Date
    July 2, 2010
    Product Code
    ORW
    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
    ORW N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies

    Other Clearances by Glaxosmithkline Consumer Healthcare

    K Number Device Name
    K093161 ACTIPROTECT UF N95 RESPIRATOR
    K081923 ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD