# LYU: Accessory, Surgical Apparel

- Device class: 1; regulation: 21 CFR 878.4040; FDA's rule: 510(k) exempt
- FDA decisions: 56
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1989: 3
- 1990: 5
- 1991: 6
- 1992: 2
- 1993: 5
- 1994: 15
- 1995: 11
- 1996: 3
- 1997: 3
- 2001: 1

## Most-cited predicates
- K011755: Stryker T4 Hytrel (R) Togas (2001), cited by 3
- K922407: Wells Lamont Cut Resistant Surgical Glove Liners (1993), cited by 2

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