FYA — Gown, Surgical Class II
FDA product code FYA covers "Gown, Surgical", a Class II medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FYA
- Device Class
- Class II
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261949 | new york embroidery studio | NYES Tuff Cuff L3 Disposable Gowns | July 10, 2026 |
| K252575 | new york embroidery studio (nyes) | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | June 4, 2026 |
| K260725 | hindernis de mexico, s.a.p.i. de c.v | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | May 12, 2026 |
| K253243 | cardinal health 200 | Cardinal Health Poly Reinforced Surgical Gown | April 28, 2026 |
| K253003 | hubei xinxin non-woven co | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); | April 20, 2026 |
| K251860 | copioumed international | Copioumed AAMI 3 Surgical Gown | February 26, 2026 |
| K252301 | yadu medical (henan) co | Henan Yadu Level 4 Surgical Gowns (Reinforced) | February 4, 2026 |
| K250564 | yadu medical (henan) co | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | December 3, 2025 |
| K243522 | thi total healthcare innovation | ViVi® Toga Premium | May 30, 2025 |
| K242937 | dae myung chemical co., ltd. (vietnam) | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | May 5, 2025 |
| K242844 | medline industries | Medline Level 4 Surgical Gown with Breathable Sleeves | February 26, 2025 |
| K241272 | stryker instruments | Stryker Steri-Shield 8 Surgical Hoods and Togas | October 16, 2024 |
| K241214 | standard textile co | ProPel SG3 Surgical Gown | September 10, 2024 |
| K233571 | george courey | GCI Surgical Gown | August 2, 2024 |
| K233068 | nanning tecbod biological technology co | Disposable Surgical Gown | March 29, 2024 |
| K233183 | ammex-weida (hubei) health and safety products co | Surgical Gown (40083) | February 1, 2024 |
| K230707 | skypro medical supplies | Skypro, Surgical Gown 6021 | October 12, 2023 |
| K230610 | dongguan shin yi healthcare products factory | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Lev | August 23, 2023 |
| K231510 | xiantao zhibo non-woven products co | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | August 22, 2023 |
| K230577 | medcare saglik urunleri sanayi ve ticaret anonim sirketi | Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) | August 16, 2023 |