510(k) · Cleared
ClearedDisposable medical mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everwin Toys (Dongguan)., Ltd. · FXX Mask, Surgical
Cleared on Jun 4, 2021 as substantially equivalent to K153409 (Protect U Guard, LLC, 2016) after a 198-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jun 4, 2021
- Review
- 198 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K970835 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 5 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 4 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 3 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 2 generations backK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
- 1 generation backK153409 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC · 2016
- This deviceK203388 Disposable medical maskEverwin Toys (Dongguan)., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −5 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −4 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −3 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −2 | K122717 | Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask | Tiger Medical Products, Ltd. | 2012 | — |
| −1 | K153409 | Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) | Protect U Guard, LLC | 2016 | — |
| 0 (this device) | K203388 | Disposable medical mask | Everwin Toys (Dongguan)., Ltd. | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FXX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FXX device
- #1 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153409 | Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Summary page 4…: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) Model: P10031, P10032, P10033, P10041, P10042, P10043 Classification Name: Mask, Surgical 510(K) Number: K153409 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II 5. Indications for Use… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K153409.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FXX
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FXX
123in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FXX
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FXX
11in 2025
MAUDE reports naming product code FXX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 7 | 144 | 0 | 9 |
| 2011 | 6 | 137 | 0 | 8 |
| 2012 | 1 | — | 0 | 22 |
| 2013 | 3 | 219 | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 5 | 298 | 0 | 14 |
| 2016 | 5 | 268 | 0 | 16 |
| 2017 | 1 | — | 0 | 45 |
| 2018 | 3 | 119 | 0 | 21 |
| 2019 | 4 | 124 | 2 | 23 |
| 2020 | 27 | 113 | 0 | 60 |
| 2021 | 218 | 162 | 0 | 67 |
| 2022 | 91 | 113 | 0 | 21 |
| 2023 | 22 | 139 | 1 | 21 |
| 2024 | 15 | 263 | 2 | 21 |
| 2025 | 6 | 123 | 0 | 11 |
| 2026 | 5 | 142 | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203388 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203388: Disposable medical mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203388
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026