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

    DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE

    K Number: K033057 · Decision Nov 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    5
    Review Days
    52

    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
    DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
    K Number
    K033057
    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
    Deroyal
    Date Received
    September 29, 2003
    Decision Date
    November 20, 2003
    Product Code
    FYA
    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
    FYA Gown, Surgical

    Similar 510(k) Clearances

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

    Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)

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

    BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

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

    Cardinal Health™ Poly Reinforced Surgical Gown

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

    Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

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

    Copioumed AAMI 3 Surgical Gown

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

    Henan Yadu Level 4 Surgical Gowns (Reinforced)

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

    Other Clearances by Deroyal

    K Number Device Name
    K041416 EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER
    K031408 DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
    K030908 DEROYAL SURGICAL DRAPES BACKTABLE COVER
    K020753 DEROYAL SURGICAL, UMBILICUP