# LYY: Latex Patient Examination Glove

- Device class: 1; regulation: 21 CFR 880.6250; FDA's rule: 510(k) required
- FDA decisions: 1,954
- 510(k) review time 2021–2025: median 143 days (middle half 99–256)
- 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)
- 2016: 4
- 2017: 4
- 2018: 2
- 2019: 1
- 2020: 1
- 2021: 8
- 2022: 14
- 2023: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K192329: Blue Latex Examination Powder Free Gloves (2019), cited by 6
- K970794: Latex Patient Examination (Powderfree Glove) (1997), cited by 5
- K202377: Palm Care Latex Examination Powder Free Gloves (2020), cited by 4
- K000671: Powdered Latex Exam Gloves, Pink, with/Without Strawberry Scent, Protein Labeling (2000), cited by 3
- K161833: Latex Examination Glove Powder Free (2017), cited by 3
- K152593: Latex Examination Glove Powder Free (2016), cited by 2
- K110250: MPXX Powder Free Natural Rubber Examination Gloves (2011), cited by 2
- K011370: Non-Sterile Powder Free Purple Latex Examination Glove with and Without Grape Scent and with Protein Labeling (50 Microg (2001), cited by 2
- K214017: Examination gloves-Type A (Latex gloves) (2022), cited by 2
- K011371: Non-Sterile Powder Free Pink Latex Examination Glove and Non-Sterile Powder Free Pink Latex Examination Glove with Straw (2001), cited by 2

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