510(k) · Cleared
ClearedDisposable 4 Layers Surgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Social Medical Supply, LLC · FXX Mask, Surgical
Cleared on Mar 2, 2023 as substantially equivalent to K221272 (Shandong Xingyu Gloves Co., Ltd., 2022) after a 49-day review. Its family tree reaches back 12 generations to 1987.
- Decided
- Mar 2, 2023
- Review
- 49 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K874608 (1987). 14 ancestors in all, the oldest K801036 (1980). No later device cites it as a predicate yet.
- Root · 12 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 8 generations between
- 3 generations backK203426 Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd. · 2021
- 2 generations backK211631 Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd. · 2021
- 1 generation backK221272 Medical Face MaskShandong Xingyu Gloves Co., Ltd. · 2022
- This deviceK230093 Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC · 2023
Show all 12 generations
- Root · 12 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 11 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 10 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 9 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 8 generations backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- 7 generations backK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
- 6 generations backK133070 SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015
- 5 generations backK153496 Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016
- 4 generations backK182514 Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd. · 2019
- 3 generations backK203426 Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd. · 2021
- 2 generations backK211631 Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd. · 2021
- 1 generation backK221272 Medical Face MaskShandong Xingyu Gloves Co., Ltd. · 2022
- This deviceK230093 Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −11 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −10 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −9 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −8 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| −7 | K131879 | KC 300 Surgical Mask | Kimberly-Clark Corp. | 2013 | 1 |
| −6 | K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | Bh Medical Products Co., Ltd. | 2015 | — |
| −5 | K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | 2016 | — |
| −4 | K182514 | Surgical Face Mask | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2019 | — |
| −3 | K203426 | Surgical Face Mask (non-sterile) | Nantong Taiweishi Medical Technology Co., Ltd. | 2021 | — |
| −2 | K211631 | Surgical Face Mask | Macheng Thimble Technology Investment Co., Ltd. | 2021 | — |
| −1 | K221272 | Medical Face Mask | Shandong Xingyu Gloves Co., Ltd. | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K221272 | Medical Face MaskSummary page 5…K230093 Regulation Number: 878.4040 Regulation Class: 2 3. Predicate Device Information 510(k) number: K221272 Sponsor: Shandong Xingyu Gloves Co., Ltd. Classification/Common Name: Surgical Face Mask Trade Name: Surg… | 2022 |
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 36 years and passes through 12 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K221272.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s), and provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230093: Disposable 4 Layers Surgical Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230093
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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