Orex Surgeon's Vest
FDA 510(k) K961083 · Thantex Specialties, Inc.
510(k) numberK961083
Submission
- Device name
- Orex Surgeon's Vest
- Applicant
- Thantex Specialties, Inc.
Norcross, GA, US - Received
- March 19, 1996
- Decision date
- August 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
| 510(k) | Device | Decision |
|---|---|---|
| K970547 | Isolyser SDS Sharps ContainerFMI · Traditional | 07/18/1997SE |
| K942200 | Isolyser Orex Surgeon's Caps, Hoods, Bouffant CapsLYU · Traditional | 08/07/1995SE |
| K943626 | Isolyser Sharps Management System SMSFMI · Traditional | 06/16/1995SE |
| K945755 | Orex(R) O.R Equipment DrapesKKX · Traditional | 05/25/1995SE |
| K945223 | Orex Isolation GownFYC · Traditional | 04/25/1995SE |
| K944859 | Orex Surgical DrapesKKX · Traditional | 02/28/1995SE |
| K944827 | Orex Surgeon's GownFYA · Traditional | 02/28/1995SE |
| K943034 | Orex Shoe CoversFXP · Traditional | 01/02/1995SE |
| K942228 | Orex O.R. TowelKKX · Traditional | 12/20/1994SE |
| K940767 | Orex (12X12 X-Ray Detectable)GDY · Traditional | 12/19/1994SE |
Questions and answers
When was Orex Surgeon's Vest cleared by the FDA?
Orex Surgeon's Vest (K961083) received a 510(k) decision of Substantially Equivalent on August 23, 1996, 157 days after the submission was received.
What is the product code of K961083?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.