# K211751: WELLTRUST WT-III Mask with Flat Earloop

- Pathway: 510(k) (Traditional)
- Applicant: Lonestar Meadows, LLC
- Decided: Sep 17, 2021 after 102 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
WELLTRUST™ WT-III Mask with Flat Earloop are indicated as a protective nose and mouth covering for patients and healthcare personnel. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid and particulate material. These surgical masks are single use, disposable devices provided non-sterile.

Source page: https://510kreport.com/device/K211751
Methodology: https://510kreport.com/methodology