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

    Protect X Level 3 Isolation Gown

    K Number: K211538 · Decision Nov 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    183

    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
    Protect X Level 3 Isolation Gown
    K Number
    K211538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Azac Group
    Date Received
    May 18, 2021
    Decision Date
    November 17, 2021
    Product Code
    FYC
    Advisory Committee
    General, Plastic Surgery
    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
    FYC Gown, Isolation, Surgical

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FYC), ordered by most recent decision date.

    Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Copioumed Chemotherapy Isolation Gown

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Disposable Isolation Gown

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Paneffort AAMI Level 3 Isolation Gown

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Azac Group

    K Number Device Name
    K242689 AAMI Level 4 Protective; Gown