# K220194: Procedure mask/Surgical mask/Face mask

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical Co., Ltd.
- Decided: May 17, 2022 after 113 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: 7 generations back to K874608 (1987). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211462: Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask, Xiantao S&J Protective Products Co., Ltd. (2021) Summary page 6.

## Most influential descendants
- K223232: Procedure mask/Surgical mask/Face mask (2023), 1 descendant of its own
- K250082: Procedure mask/Surgical mask/Face mask (2025), 0 descendants of its own

## Indications for use
The Procedure mask/Surgical mask/Face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K220194
Methodology: https://510kreport.com/methodology