# FMC: Patient Examination Glove

- Device class: 1; regulation: 21 CFR 880.6250; FDA's rule: 510(k) required
- FDA decisions: 34
- 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)
- 1988: 2
- 1989: 2
- 1990: 3
- 1991: 1
- 1992: 2
- 1993: 1
- 1994: 2
- 1999: 1
- 2002: 1
- 2004: 1

## Most-cited predicates
- K014134: Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G) (2002), cited by 2
- K905109: Patient Examination Glove/Hypoallergenic (1990), cited by 1
- K932404: Nitrile Rubber Powder-Free Examination Glove (1994), cited by 1

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