# MMP: Cover, Barrier, Protective

- Device class: 2; regulation: 21 CFR 878.4370; FDA's rule: 510(k) required
- FDA decisions: 15
- Recalls: 19 (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)
- 1982: 1
- 1994: 2
- 1995: 2
- 1996: 1
- 1997: 2
- 2002: 1
- 2003: 2
- 2004: 2
- 2005: 1
- 2009: 1

## Most-cited predicates
- K931417: Sterile Equipment Covers (1995), cited by 5
- K961699: Equipment Covers (1996), cited by 4
- K032065: Medline Band Bags and Equipment Covers (2003), cited by 4
- K962288: Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest Cover (1997), cited by 2
- K944198: Surgical Microscope Drape (1994), cited by 1
- K023540: Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09 (2003), cited by 1
- K014239: Medsurg Equipment Covers (2002), cited by 1
- K952241: Protouch Overglove (1995), cited by 1
- K043234: Light Drape (2005), cited by 1

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