Home / 510(k) Clearances / K193327

510(k) K193327

Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve by Cardinal Health200, LLC — Product Code FYA

K193327 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve". The FDA issued a decision of Substantially Equivalent on March 20, 2020. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Cardinal Health200, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2020
Date Received
December 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Cardinal Health200, LLC

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  • K230838 — Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrumen (July 27, 2023)
  • K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject M (June 21, 2023)
  • K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD E (April 3, 2023)
  • K201592 — Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove (September 26, 2021)
  • K211390 — Nitrile Blue Powder-free Examination Glove (August 28, 2021)
  • K200824 — Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AI (July 29, 2020)
  • K192374 — Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (December 2, 2019)
  • K182830 — Cardinal HealthTM Poly-Coated Open-Back Protective Gown (April 26, 2019)
  • K181174 — Cardinal Health Sterilization Wrap (December 11, 2018)

Other clearances for product code FYA

  • K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (R (August 26, 2026)
  • K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) (August 7, 2026)
  • K261949 — NYES Tuff Cuff L3 Disposable Gowns (July 10, 2026)
  • K252575 — Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (June 4, 2026)
  • K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (May 12, 2026)
  • K253243 — Cardinal Health™ Poly Reinforced Surgical Gown (April 28, 2026)
  • K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); (April 20, 2026)
  • K251860 — Copioumed AAMI 3 Surgical Gown (February 26, 2026)
  • K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced) (February 4, 2026)
  • K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (December 3, 2025)

FDA data resources