Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
FDA 510(k) K230610 · Dongguan Shin YI Healthcare Products Factory
510(k) numberK230610
Submission
- Device name
- Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
- Applicant
- Dongguan Shin YI Healthcare Products Factory
Dong Guan, CN - Received
- March 6, 2023
- Decision date
- August 23, 2023
- 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 |
|---|---|---|
| K210372 | Disposable Surgical MaskFXX · Traditional | 06/07/2021SE |
Questions and answers
When was Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) cleared by the FDA?
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) (K230610) received a 510(k) decision of Substantially Equivalent on August 23, 2023, 170 days after the submission was received.
What is the product code of K230610?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.