# K202096: 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On

- Pathway: 510(k) (Traditional)
- Applicant: Ecoguard, Inc.
- Decided: Feb 2, 2021 after 188 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: 8 generations back to K874608 (1987). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153496: Disposable Surgical Face Mask, Xiantao Rayxin Medical Products Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K220378: Sparta 3-Ply Surgical Disposable Face Mask (2022), 0 descendants of its own
- K211097: Banyan USA Surgical Mask Level 3 (2021), 0 descendants of its own

## Indications for use
The Following EcoGuard Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. These surgical masks are single use, disposable devices provided non-sterile. 3-ply EcoGuard B with Earloop, Model Number: ECO01 3-ply EcoGuard B with Tie-on, Model Number: ECO02

Source page: https://510kreport.com/device/K202096
Methodology: https://510kreport.com/methodology