# FYA: Gown, Surgical

- Device class: 2; regulation: 21 CFR 878.4040; FDA's rule: 510(k) required
- FDA decisions: 298
- 510(k) review time 2021–2025: median 170 days (middle half 119–270)
- Recalls: 81 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 4
- 2018: 2
- 2019: 5
- 2020: 7
- 2021: 17
- 2022: 24
- 2023: 12
- 2024: 5
- 2025: 4
- 2026: 9

## Most-cited predicates
- K170762: Cardinal Health Non-Reinforced Surgical Gown (2017), cited by 8
- K211422: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (2021), cited by 6
- K080795: Ultra Surgical Gown & Fluid Barrier Surgical Gown (2008), cited by 5
- K202706: Surgical Gown (Sterile), Surgical Gown (Non-sterile) (2020), cited by 5
- K192290: 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown (2020), cited by 5
- K190950: Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) (2019), cited by 5
- K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) (2018), cited by 5
- K981393: Microcool Surgical Gown (1998), cited by 3
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), cited by 3
- K052550: Imc Surgical Gowns (2005), cited by 3

Source page: https://510kreport.com/product-code/FYA
Data by year (CSV): https://510kreport.com/product-code/FYA.csv