# QPC: Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

- Device class: 2; regulation: 21 CFR 878.4040; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 207 days (middle half 128–319)
- Recalls: 0 (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: 1
- 2019: 1
- 2021: 2
- 2022: 1
- 2023: 2
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K160337: Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns (2017), cited by 3
- K182830: Cardinal HealthTM Poly-Coated Open-Back Protective Gown (2019), cited by 1
- K233526: Medline Open-back Level 3 Protective Gown (2024), cited by 1
- K210405: ProTEC-USA EZDoff Gown (2021), cited by 1

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