# OPE: FDA product code

- Device class: —; regulation: 21 CFR —
- FDA decisions: 3
- 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)

## Most-cited predicates
- K895642: Latex Patient Examination Gloves (1989), cited by 1

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