# NAB: Gauze / Sponge,Nonresorbable For External Use

- Device class: 1; regulation: 21 CFR 878.4014; FDA's rule: 510(k) exempt
- FDA decisions: 88
- Recalls: 3 (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)
- 1984: 1
- 1986: 1
- 1987: 2
- 1988: 1
- 1989: 7
- 1991: 15
- 1992: 11
- 1993: 5
- 1994: 1
- 1995: 1

## Most-cited predicates
- K830473: Nova Gauze (1983), cited by 1
- K891101: Non-Absorbable Gauze, Surgical Sponge & Dressing (1989), cited by 1
- K820198: Derma-Aid (1982), cited by 1
- K914604: Mepitel Non-Adherent Silicone Dressing (1992), cited by 1

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