# LYZ: Vinyl Patient Examination Glove

- Device class: 1; regulation: 21 CFR 880.6250; FDA's rule: 510(k) required
- FDA decisions: 799
- 510(k) review time 2021–2025: median 92 days (middle half 78–112)
- Recalls: 6 (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)
- 2017: 9
- 2018: 10
- 2019: 4
- 2020: 4
- 2021: 30
- 2022: 10
- 2023: 2
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K032908: Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves (2003), cited by 75
- K032907: Fuguan (Brand) Powdered Vinyl Patient Examination Gloves (2003), cited by 29
- K992821: Synthetic Powder-Free Vinyl Patient Examination Gloves (2000), cited by 18
- K091663: Powder-Free Vinyl Patient Examination Gloves (2009), cited by 18
- K163168: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) (2017), cited by 17
- K051156: Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow) (2005), cited by 15
- K120968: Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored) (2012), cited by 14
- K992861: Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves (1999), cited by 11
- K153028: Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue (2016), cited by 9
- K000071: Synthetic Powder Free (White) Vinyl Patient Examination Gloves (2000), cited by 9

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