Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown (Sterile) (Non Sterile)
FDA 510(k) K093169 · A Plus International, Inc.
510(k) numberK093169
Submission
- Device name
- Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown (Sterile) (Non Sterile)
- Applicant
- A Plus International, Inc.
Chino, CA, US - Received
- October 7, 2009
- Decision date
- November 12, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K213001 | Procedure Mask, Surgical MaskFXX · Traditional | 05/11/2022SE |
| K102861 | Surgiplus SMS Surgical Drape (Sterile/Non-Sterile), Surgiplus SPP with Pe Laminated…KKX · Traditional | 01/13/2011SE |
| K031353 | Solution Face MasksFXX · Traditional | 06/19/2003SE |
| K882284 | Surgeons CapFYF · Traditional | 06/23/1988SE |
| K882283 | Bouffant CapFYF · Traditional | 06/23/1988SE |
| K882282 | Suit, SurgicalFXO · Traditional | 06/23/1988SE |
| K882281 | Gown, Isolation, Surgical (Fyc)FYC · Traditional | 06/23/1988SE |
| K882280 | Cover, Shoe Operating RoomFXP · Traditional | 06/23/1988SE |
| K881396 | Operating Room Towels -Sterile & Non-SterileKKX · Traditional | 04/29/1988SE |
| K881395 | Gauze and Lap Sponges -Sterile & Non-SterileEFQ · Traditional | 04/28/1988SE |
Questions and answers
When was Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown (Sterile) (Non Sterile) cleared by the FDA?
Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown (Sterile) (Non Sterile) (K093169) received a 510(k) decision of Substantially Equivalent on November 12, 2009, 36 days after the submission was received.
What is the product code of K093169?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.