Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N
FDA 510(k) K061308 · Cardinal Health 200, Inc.
510(k) numberK061308
Submission
- Device name
- Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N
- Applicant
- Cardinal Health 200, Inc.
Waukegan, IL, US - Received
- May 10, 2006
- Decision date
- June 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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.
Questions and answers
When was Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N cleared by the FDA?
Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N (K061308) received a 510(k) decision of Substantially Equivalent on June 5, 2006, 26 days after the submission was received.
What is the product code of K061308?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.