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

    Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve

    K Number: K193327 · Decision Mar 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    26
    Review Days
    109

    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
    Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
    K Number
    K193327
    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
    Cardinal Health200, LLC
    Date Received
    December 2, 2019
    Decision Date
    March 20, 2020
    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 Cardinal Health200, LLC

    K Number Device Name
    K241780 Cardinal Health Nitrile Exam Gloves
    K230838 Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets
    K223376 Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
    K230028 Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
    K201592 Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
    K211390 Nitrile Blue Powder-free Examination Glove
    K200824 Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
    K192374 Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
    K182830 Cardinal HealthTM Poly-Coated Open-Back Protective Gown
    K181174 Cardinal Health Sterilization Wrap
    Search all 26 clearances from Cardinal Health200, LLC →