Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
FDA 510(k) K200824 · Cardinal Health200, LLC
510(k) numberK200824
Submission
- Device name
- Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
- Applicant
- Cardinal Health200, LLC
Waukegan, IL, US - Received
- March 30, 2020
- Decision date
- July 29, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FYA – Gown, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FYA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns…FYA · Traditional | Principle & Will Co., Ltd. | 08/26/2026SE |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 08/07/2026SE |
| K261949 | NYES Tuff Cuff L3 Disposable GownsFYA · Special | New York Embroidery Studio | 07/10/2026SE |
| K252575 | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)FYA · Traditional | New York Embroidery Studio (NYES) | 06/04/2026SE |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)FYA · Traditional | Hindernis DE Mexico, S.A.P.I. DE C.V. | 05/12/2026SE |
| K253243 | Cardinal Health Poly Reinforced Surgical GownFYA · Abbreviated | Cardinal Health 200, LLC | 04/28/2026SE |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…FYA · Traditional | Hubei Xinxin Non-Woven Co., Ltd. | 04/20/2026SE |
| K251860 | Copioumed AAMI 3 Surgical GownFYA · Traditional | Copioumed International, Inc. | 02/26/2026SE |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 02/04/2026SE |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 12/03/2025SE |
More from Yadu Medical (Henan) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K241780 | Cardinal Health Nitrile Exam GlovesLZA · Special | 08/23/2024SE |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument PocketsFYA · Traditional | 07/27/2023SE |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated | 06/21/2023SE |
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express…JOW · Traditional | 04/03/2023SE |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveKGO · Traditional | 09/26/2021SE |
| K211390 | Nitrile Blue Powder-free Examination GloveLZA · Traditional | 08/28/2021SE |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus…FYA · Traditional | 03/20/2020SE |
| K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam StripFXX · Traditional | 12/02/2019SE |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective GownQPC · Traditional | 04/26/2019SE |
| K181174 | Cardinal Health Sterilization WrapFRG · Traditional | 12/11/2018SE |
Questions and answers
When was Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown cleared by the FDA?
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown (K200824) received a 510(k) decision of Substantially Equivalent on July 29, 2020, 121 days after the submission was received.
What is the product code of K200824?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.