Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
FDA 510(k) K211765 · Cardinal Health, LLC
510(k) numberK211765
Submission
- Device name
- Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
- Applicant
- Cardinal Health, LLC
Waukegan, IL, US - Received
- June 8, 2021
- Decision date
- November 23, 2021
- 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.
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| K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD…LZH · Traditional | 12/20/2022SE |
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use…KGO · Traditional | 06/15/2017SE |
| K160411 | Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingLYZ · Traditional | 07/25/2016SE |
| K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with…KGO · Traditional | 07/11/2016SE |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and…KGO · Traditional | 05/12/2016SE |
| K122696 | Powder-Free Nitrile Examination Gloves (Cool Blue)LZA · Traditional | 01/31/2013SE |
| K121897 | Protexis Latex Basic Sterile Powder-Free Surgical GlovesKGO · Special | 07/27/2012SE |
| K120934 | Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein Content Label…KGO · Traditional | 05/23/2012SE |
| K111878 | Protexis Latex Blue with Neu-Thera Powder-Free Surgical GlovesKGO · Traditional | 09/29/2011SE |
| K110272 | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugKGO · Traditional | 06/08/2011SE |
Questions and answers
When was Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown cleared by the FDA?
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown (K211765) received a 510(k) decision of Substantially Equivalent on November 23, 2021, 168 days after the submission was received.
What is the product code of K211765?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.