# K211105: Ear-Friendly Mask

- Pathway: 510(k) (Traditional)
- Applicant: Ray Co., Ltd.
- Decided: May 17, 2021 after 34 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: 2 generations back to K911334 (1991). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200847: Surgical Face Mask, Mexpo International, Inc. (2020) Summary page 6.

## Most influential descendants
- K212398: Surgical Face Mask (Non-sterile) (2021), 1 descendant of its own
- K222335: Surgical Mask (2022), 0 descendants of its own

## Indications for use
When properly worn, the Ear-Friendly Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.

Source page: https://510kreport.com/device/K211105
Methodology: https://510kreport.com/methodology