Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
FDA 510(k) K252575 · New York Embroidery Studio (NYES)
510(k) numberK252575
Submission
- Device name
- Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- Applicant
- New York Embroidery Studio (NYES)
New York, NY, US - Received
- August 14, 2025
- Decision date
- June 4, 2026
- 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 |
| 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 |
| K243522 | ViVi® Toga PremiumFYA · Traditional | Thi Total Healthcare Innovation GmbH | 05/30/2025SE |
Questions and answers
When was Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) cleared by the FDA?
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (K252575) received a 510(k) decision of Substantially Equivalent on June 4, 2026, 294 days after the submission was received.
What is the product code of K252575?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.