# K203388: Disposable medical mask

- Pathway: 510(k) (Traditional)
- Applicant: Everwin Toys (Dongguan)., Ltd.
- Decided: Jun 4, 2021 after 198 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: 6 generations back to K970835 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153409: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green), Protect U Guard, LLC (2016) Summary page 4.

## Indications for use
The Disposable medical masks are intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile. Model: WSKZ-001 Color : Blue

Source page: https://510kreport.com/device/K203388
Methodology: https://510kreport.com/methodology