# K210772: 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)

- Pathway: 510(k) (Traditional)
- Applicant: Vr Vertical, LLC Dba Xrgo
- Decided: Sep 22, 2021 after 191 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
This single-use face mask covers the wearer's nose and mouth, providing a general physical barrier to protect the wearer from the environment, and the environment from the wearer. This device is designed to be resistant to splash and spatter of blood and other infectious materials.

Source page: https://510kreport.com/device/K210772
Methodology: https://510kreport.com/methodology