510(k) · Cleared
ClearedKimberly-Clark KC100 Surgical Gown, Model KC100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · FYA Gown, Surgical
Cleared on Mar 19, 2010 as substantially equivalent to K091097 (Promedical Products Co., Ltd., 2009) after a 168-day review. Its family tree reaches back 1 generation to 2009. 9 later devices descend from it.
- Decided
- Mar 19, 2010
- Review
- 168 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091097 (2009). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK091097 Promedical Surgical Gown, Models 18-301, 18-401 and 18-501Promedical Products Co., Ltd. · 2009
- This deviceK093115 Kimberly-Clark KC100 Surgical Gown, Model KC100Kimberly-Clark Corp. · 2010
- Descendant · cites it directly · 8 of its ownK102652 Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns…Gri Medical & Electronic Technology Co., Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK121152 Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd. · 2012
- Descendant · 3 generations on · 3 of its ownK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK141467 Surgical GownXuchang Zhengde Environstar Medical Products Co.,L · 2015
- Descendant · 4 generations on · 0 of its ownK253003 Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical…Hubei Xinxin Non-Woven Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K102652Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced…Gri Medical & Electronic Technology Co., Ltd. · 2011 · cites it directly8descendants
- K121152Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd. · 2012 · 2 generations on7descendants
- K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021 · 3 generations on3descendants
- K141467Surgical GownXuchang Zhengde Environstar Medical Products Co.,L · 2015 · 2 generations on1descendant
- K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091097 | Promedical Surgical Gown, Models 18-301, 18-401 and 18-501 | Promedical Products Co., Ltd. | 2009 | — |
| 0 (this device) | K093115 | Kimberly-Clark KC100 Surgical Gown, Model KC100 | Kimberly-Clark Corp. | 2010 | — |
| +1 | K102652 | Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric… | Gri Medical & Electronic Technology Co., Ltd. | 2011 | — |
| +2 | K121152 | Surgical Gown, SMS | Jiangsu Guangda Medical Material, Co., Ltd. | 2012 | — |
| +3 | K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Fugou County Shenxiang Manufacturing Co., Ltd. | 2021 | — |
| +2 | K141467 | Surgical Gown | Xuchang Zhengde Environstar Medical Products Co.,L | 2015 | — |
| +4 | K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown… | Hubei Xinxin Non-Woven Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 FYA? 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 FYA device
- #1 K211422 Level 2 Standard Surgical Gown, Level 3…score 20.8 · 5 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 |
|---|---|---|---|
| * | K091097 | Promedical Surgical Gown, Models 18-301, 18-401 and 18-501Summary page 1…rile surgical gowns Name: Trade Name: KC100 Surgical Gowns Device Product FYA Surgical Gowns Codes and Classification Names: Predicate Device: K091097 proMedical Surgical Gowns Device Disposable gowns are used in the OR as a protective Description: coveri… | 2009 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102652 | Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced… | 2011 | 8 |
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?
- Its one ancestor has no recall.
- Of its descendants, K102652 (Gri Medical & Electronic Technology Co., Ltd., 2011) has gone furthest, with 8 descendants of its own.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FYA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FYA
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYA
1in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · FYA
14in 2025
MAUDE reports naming product code FYA, 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 | 6 | 110 | 2 | 8 |
| 2008 | 4 | 207 | 0 | 3 |
| 2009 | 6 | 98 | 0 | 18 |
| 2010 | 4 | 128 | 2 | 9 |
| 2011 | 8 | 141 | 0 | 16 |
| 2012 | 4 | 202 | 1 | 43 |
| 2013 | 2 | — | 0 | 71 |
| 2014 | 5 | 120 | 9 (9) | 42 |
| 2015 | 3 | 275 | 0 | 59 |
| 2016 | 3 | 155 | 0 | 43 |
| 2017 | 4 | 111 | 0 | 66 |
| 2018 | 2 | — | 1 | 98 |
| 2019 | 5 | 105 | 0 | 38 |
| 2020 | 7 | 114 | 40 | 31 |
| 2021 | 17 | 163 | 11 | 15 |
| 2022 | 24 | 177 | 2 | 4 |
| 2023 | 12 | 190 | 1 | 12 |
| 2024 | 5 | 163 | 0 | 27 |
| 2025 | 4 | 210 | 1 | 14 |
| 2026 | 9 | 198 | 2 | — |
What is it indicated for?
The Kimberly-Clark* KC100 Surgical Gowns are sterile, single use devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
The Kimberly-Clark* KC100 Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093115: Kimberly-Clark KC100 Surgical Gown, Model KC100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093115
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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