510(k) · Cleared
Recalled · Class II · 2020Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health 200, Inc. · FYA Gown, Surgical
Cleared on Jun 5, 2006 after a 26-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 5, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 6
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK061308 Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and…Cardinal Health 200, Inc. · 2006
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K061308 | Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and… | Cardinal Health 200, Inc. | 2006 | — |
| +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 |
|---|---|---|---|
| * | — | Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, Breathable Surgical Gowns… Named without a submission number |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2020 | Class II | Z-1005-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1017-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1002-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1004-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1006-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1008-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 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.
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?
Convertors® Surgical gowns are made from natural and synthetic materials that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The gown is a single use disposable device intended for repackaging and sterilization before use. This single use product is a disposable non-sterile…
Read the full statement (160 words)
Convertors® Surgical gowns are made from natural and synthetic materials that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The gown is a single use disposable device intended for repackaging and sterilization before use.
This single use product is a disposable non-sterile surgical gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization and Ethylene Oxide following the Validation and Routine Control under ANSI/AMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health, Inc,
The exception for sterilization is that the SMS polyolefin reinforced gown, cannot under go steam sterilization. Steam sterilization may damage the impervious reinforcement on the gown. Ethylene Oxide is the only method of sterilization for this gown.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061308 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061308: Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061308
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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