# LZC: Medical Glove, Specialty

- Device class: 1; regulation: 21 CFR 880.6250; FDA's rule: 510(k) required
- FDA decisions: 79
- 510(k) review time 2021–2025: median 88 days (middle half 72–102)
- Recalls: 7 (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)
- 2015: 1
- 2016: 3
- 2017: 6
- 2018: 6
- 2019: 7
- 2020: 3
- 2021: 3
- 2022: 7
- 2025: 1
- 2026: 1

## Most-cited predicates
- K141982: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs (2015), cited by 7
- K201390: Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) (2020), cited by 6
- K081089: Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim (2008), cited by 5
- K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2017), cited by 5
- K992162: Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim (1999), cited by 3
- K180646: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (2018), cited by 3
- K193555: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (2020), cited by 2
- K102790: Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Deramatitis Potential and Chemotherapy Drug (2010), cited by 2
- K200633: Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (2020), cited by 2
- K173942: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2018), cited by 2

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