# KGO: Surgeon'S Gloves

- Device class: 1; regulation: 21 CFR 878.4460; FDA's rule: 510(k) required
- FDA decisions: 560
- 510(k) review time 2021–2025: median 183 days (middle half 127–252)
- Recalls: 34 (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: 12
- 2018: 7
- 2019: 11
- 2020: 15
- 2021: 14
- 2022: 6
- 2023: 14
- 2024: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K013302: Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim (2001), cited by 6
- K050184: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove (2005), cited by 5
- K192328: JR.MEDIK Latex Surgeon’s Gloves Powder Free (2020), cited by 5
- K981096: Sempermed Surgeons' Gloves - Supreme (1998), cited by 4
- K011721: Esteem Sterile Polyisoprene Surgical Gloves (2001), cited by 4
- K110272: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug (2011), cited by 3
- K063757: Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves (2007), cited by 3
- K980942: Regent Biogel Indicator Inner Surgical Glove (1998), cited by 3
- K151694: Gammex PI Hybrid Surgical Gloves (2016), cited by 2
- K111139: Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U (2011), cited by 2

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