510(k) · Cleared
ClearedLevel 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Lanhine Medical Products, Ltd. · FXX Mask, Surgical
Cleared on Sep 23, 2021 as substantially equivalent to K200923 (Byd Precision Manufacturer Co., Ltd., 2020) after a 101-day review. Its family tree reaches back 9 generations to 1987. 6 later devices descend from it.
- Decided
- Sep 23, 2021
- Review
- 101 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). 6 later devices descend from it, 4 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 backK200923 Single-use Surgical MaskByd Precision Manufacturer Co., Ltd. · 2020
- This deviceK211827 Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)Zhejiang Lanhine Medical Products, Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK213806 Disposable Medical Face MaskXiantao Zhibo Nonwoven Products Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK213601 Surgical MaskWuhan Zonsen Medical Products Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK223055 Disposable Medical Face MaskXiantao Zhuobo Industrial Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK222697 Disposable Medical Face Mask (DF3-001)Wellmed Dental Medical Supply Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK221976 Surgical Face Mask (Non-sterile)Xiantao Junhui Plastic Products Co., Ltd. · 2022
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 backK200923 Single-use Surgical MaskByd Precision Manufacturer Co., Ltd. · 2020
- This deviceK211827 Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)Zhejiang Lanhine Medical Products, Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213806Disposable Medical Face MaskXiantao Zhibo Nonwoven Products Co., Ltd. · 2022 · cites it directly2descendants
- K213601Surgical MaskWuhan Zonsen Medical Products Co., Ltd. · 2022 · cites it directly0descendants
- K223055Disposable Medical Face MaskXiantao Zhuobo Industrial Co., Ltd. · 2022 · 2 generations on0descendants
- K222697Disposable Medical Face Mask (DF3-001)Wellmed Dental Medical Supply Co., Ltd. · 2022 · 2 generations on0descendants
- K221976Surgical Face Mask (Non-sterile)Xiantao Junhui Plastic Products Co., Ltd. · 2022 · cites it directly0descendants
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 | K200923 | Single-use Surgical Mask | Byd Precision Manufacturer Co., Ltd. | 2020 | — |
| 0 (this device) | K211827 | Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) | Zhejiang Lanhine Medical Products, Ltd. | 2021 | — |
| +1 | K213806 | Disposable Medical Face Mask | Xiantao Zhibo Nonwoven Products Co., Ltd. | 2022 | — |
| +1 | K213601 | Surgical Mask | Wuhan Zonsen Medical Products Co., Ltd. | 2022 | — |
| +2 | K223055 | Disposable Medical Face Mask | Xiantao Zhuobo Industrial Co., Ltd. | 2022 | — |
| +2 | K222697 | Disposable Medical Face Mask (DF3-001) | Wellmed Dental Medical Supply Co., Ltd. | 2022 | — |
| +1 | K221976 | Surgical Face Mask (Non-sterile) | Xiantao Junhui Plastic Products Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2022 | 6 | 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 |
|---|---|---|---|
| * | K200923 | Single-use Surgical MaskSummary page 4…Review Panel: Surgical Apparel C. Predicate device: 510K Device name ASTM F2100 level Manufacturer K200923 Single-use Surgical Masks Level 3 BYD Precision Manufacturer Co. Ltd D. Indications for use o… | 2020 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K213806 (Xiantao Zhibo Nonwoven Products Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K200923.
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 Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) are 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211827 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211827: Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211827
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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