510(k) · Cleared
ClearedSurgical Face Masks (Ear loops and Tie-on)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
San-M Package Co., Ltd. · FXX Mask, Surgical
Cleared on Sep 6, 2016 as substantially equivalent to K110455 (Kimberly-Clark Corp., 2011) and 1 other predicate after a 217-day review. Its family tree reaches back 5 generations to 1987. 60 later devices descend from it.
- Decided
- Sep 6, 2016
- Review
- 217 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K874608 (1987). 7 ancestors in all, the oldest K801036 (1980). 60 later devices descend from it, 39 citing it directly.
- Root · 5 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 4 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 3 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 2 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 1 generation backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- This deviceK160269 Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK202491 Disposable Surgical Face MaskJiangsu Newvalue Medical Products Co., Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK212293 Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)Jiangmen Ningrui Medical Supplies Co., Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK211462 Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical…Xiantao S&J Protective Products Co., Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK202424 Surgical Mask-Models CR02-2, CR02Foshan Xinbao Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK220194 Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd. · 2022
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K202491Disposable Surgical Face MaskJiangsu Newvalue Medical Products Co., Ltd. · 2021 · cites it directly4descendants
- K212293Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)Jiangmen Ningrui Medical Supplies Co., Ltd. · 2021 · 2 generations on3descendants
- K211462Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face MaskXiantao S&J Protective Products Co., Ltd. · 2021 · cites it directly3descendants
- K202424Surgical Mask-Models CR02-2, CR02Foshan Xinbao Technology Co., Ltd. · 2021 · cites it directly3descendants
- K220194Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −4 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −3 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −2 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −1 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| 0 (this device) | K160269 | Surgical Face Masks (Ear loops and Tie-on) | San-M Package Co., Ltd. | 2016 | — |
| +1 | K202491 | Disposable Surgical Face Mask | Jiangsu Newvalue Medical Products Co., Ltd. | 2021 | — |
| +2 | K212293 | Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) | Jiangmen Ningrui Medical Supplies Co., Ltd. | 2021 | — |
| +1 | K211462 | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask | Xiantao S&J Protective Products Co., Ltd. | 2021 | — |
| +1 | K202424 | Surgical Mask-Models CR02-2, CR02 | Foshan Xinbao Technology Co., Ltd. | 2021 | — |
| +2 | K220194 | Procedure mask/Surgical mask/Face mask | Winner Medical 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 |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 29 | 0 |
| 2022 | 21 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face MasksSummary page 4…Predicate Device The Surgical Face Masks (Ear loops and Tie-on) are substantially equivalent to the Kimberly-Clark KC100 Mask (K110455) and KC200 and KC300 Face Masks (K111402). A comparison between the p… | 2011 |
| * | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300…Summary page 4…e-on) are substantially equivalent to the Kimberly-Clark KC100 Mask (K110455) and KC200 and KC300 Face Masks (K111402). A comparison between the proposed and predicate devices is shown in Table 5-A below. Table 5-A.… | 2011 |
What descends from it? (60)
See all 6039 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202491 | Disposable Surgical Face Mask | 2021 | 4 |
| K211462 | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask | 2021 | 3 |
| K202424 | Surgical Mask-Models CR02-2, CR02 | 2021 | 3 |
| K202903 | Surgical Face Mask | 2022 | 2 |
| K211454 | Surgical mask | 2021 | 2 |
| K202061 | Medical Face mask | 2020 | 2 |
| K212120 | Surgical Masks | 2022 | 1 |
| K212471 | Medical Face Mask | 2021 | 1 |
| K210622 | Single-Use Medical Face Mask | 2021 | 1 |
| K202598 | 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3… | 2021 | 1 |
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 29 years and passes through 6 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K202491 (Jiangsu Newvalue Medical Products Co., Ltd., 2021) has gone furthest, with 4 descendants of its own.
- 18 other devices also cite its predicate K110455.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 masks 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 is a single-use, disposable device, provided non-sterile.
Level 1 Face Mask Models: # EL 10000, EL 10010, TO 10000, TO 10010
Level 2 Face Mask Models: # EL 20000, EL 20010, TO 20000, TO 20010
Level 3 Face Mask Models: # EL 30000, EL 30010, TO 30000, TO 30010
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/K160269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160269: Surgical Face Masks (Ear loops and Tie-on).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160269
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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