# K211097: Banyan USA Surgical Mask Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Banyan USA, LLC
- Decided: Sep 22, 2021 after 162 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K874608 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202096: 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On, Ecoguard, Inc. (2021) Summary page 4.

## Indications for use
The Banyan USA Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganism, body fluids, and particulate materials. This face mask are intended for use in infection control practices to reduce potential exposure to blood and body fluids. the face mask is single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K211097
Methodology: https://510kreport.com/methodology