# LZA: Polymer Patient Examination Glove

- Device class: 1; regulation: 21 CFR 880.6250; FDA's rule: 510(k) required
- FDA decisions: 1,181
- 510(k) review time 2021–2025: median 105 days (middle half 84–173)
- Recalls: 5 (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: 44
- 2018: 22
- 2019: 25
- 2020: 30
- 2021: 139
- 2022: 146
- 2023: 62
- 2024: 30
- 2025: 24
- 2026: 15

## Most-cited predicates
- K171422: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color (2018), cited by 45
- K192333: Blue Nitrile Examination Gloves Powder Free (2020), cited by 24
- K120970: Nitrile Powder Free Patient Examination Gloves, Colored (Blue) (2012), cited by 18
- K190860: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color (2019), cited by 12
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl (2020), cited by 11
- K203593: Patient Examination Gloves (2021), cited by 11
- K150340: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) (2015), cited by 9
- K190942: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color (2020), cited by 9
- K202384: Palm Care Blue Nitrile Examination Gloves Powder Free (2020), cited by 8
- K993247: Nitrile Powder Free Patient Examination Gloves (1999), cited by 7

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