510(k) · Cleared
ClearedSurgical Face Mask (non-sterile)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nantong Taiweishi Medical Technology Co., Ltd. · FXX Mask, Surgical
Cleared on Feb 18, 2021 as substantially equivalent to K182514 (Xiantao Zhibo Non-Woven Products Co., Ltd., 2019) after a 90-day review. Its family tree reaches back 9 generations to 1987. 13 later devices descend from it.
- Decided
- Feb 18, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K874608 (1987). 11 ancestors in all, the oldest K801036 (1980). 13 later devices descend from it, 8 citing it directly.
- Root · 9 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 5 generations between
- 3 generations backK133070 SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015
- 2 generations backK153496 Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016
- 1 generation backK182514 Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd. · 2019
- This deviceK203426 Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK211631 Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK221272 Medical Face MaskShandong Xingyu Gloves Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK213617 Surgical Face MaskMegasoft (China) Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK230617 Surgical Face Mask (L 175*95mm)Henan Chaoya Medical Equipment Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK230093 Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC · 2023
Show all 9 generations
- Root · 9 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 8 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 7 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 6 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 5 generations backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- 4 generations backK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
- 3 generations backK133070 SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015
- 2 generations backK153496 Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016
- 1 generation backK182514 Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd. · 2019
- This deviceK203426 Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K211631Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd. · 2021 · cites it directly4descendants
- K221272Medical Face MaskShandong Xingyu Gloves Co., Ltd. · 2022 · 2 generations on2descendants
- K213617Surgical Face MaskMegasoft (China) Co., Ltd. · 2022 · cites it directly1descendant
- K230617Surgical Face Mask (L 175*95mm)Henan Chaoya Medical Equipment Co., Ltd. · 2023 · 3 generations on0descendants
- K230093Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −8 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −7 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −6 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −5 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| −4 | K131879 | KC 300 Surgical Mask | Kimberly-Clark Corp. | 2013 | 1 |
| −3 | K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | Bh Medical Products Co., Ltd. | 2015 | — |
| −2 | K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | 2016 | — |
| −1 | K182514 | Surgical Face Mask | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2019 | — |
| 0 (this device) | K203426 | Surgical Face Mask (non-sterile) | Nantong Taiweishi Medical Technology Co., Ltd. | 2021 | — |
| +1 | K211631 | Surgical Face Mask | Macheng Thimble Technology Investment Co., Ltd. | 2021 | — |
| +2 | K221272 | Medical Face Mask | Shandong Xingyu Gloves Co., Ltd. | 2022 | — |
| +1 | K213617 | Surgical Face Mask | Megasoft (China) Co., Ltd. | 2022 | — |
| +3 | K230617 | Surgical Face Mask (L 175*95mm) | Henan Chaoya Medical Equipment Co., Ltd. | 2023 | — |
| +3 | K230093 | Disposable 4 Layers Surgical Face Mask | Social Medical Supply, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
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 |
|---|---|---|---|
| * | K182514 | Surgical Face MaskSummary page 5…ation Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel C. Predicate device: K182514 Surgical Face Mask D. Indications use of the device: The Surgical Face Mask（non-sterile）is intended to be worn to protect both t… | 2019 |
What descends from it? (13)
See all 138 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211631 | Surgical Face Mask | 2021 | 4 |
| K213617 | Surgical Face Mask | 2022 | 1 |
| K220749 | Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP | 2022 | 0 |
| K212526 | Surgical Face Mask | 2021 | 0 |
| K211794 | Disposable surgical mask | 2021 | 0 |
| K211353 | Medical Face Mask | 2021 | 0 |
| K211363 | Medical Face Mask | 2021 | 0 |
| K211062 | Medical Face Mask | 2021 | 0 |
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 34 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K211631 (Macheng Thimble Technology Investment Co., Ltd., 2021) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K182514.
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 Surgical Face Mask (non-sterile) 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 a single use, disposable device(s),
provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203426: Surgical Face Mask (non-sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203426
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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