510(k) · Cleared
ClearedDisposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
String King Lacrosse, LLC · FYC Gown, Isolation, Surgical
Cleared on Nov 24, 2021 as substantially equivalent to K202310 (Wildcat Ppe, LLC, 2021) after a 97-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Nov 24, 2021
- Review
- 97 days
- Class
- Class II
- Product code
- FYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952116 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK952116 Cover GownAmerican Threshold Industries, Inc. · 1995
- 2 generations backK160339 Cardinal Health Isolation GownCardinal Health200, LLC · 2016 · Recalled
- 1 generation backK202310 Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical…Wildcat Ppe, LLC · 2021
- This deviceK212633 Disposable Isolation Gown -Level 3, Large, Blue, Disposable…String King Lacrosse, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952116 | Cover Gown | American Threshold Industries, Inc. | 1995 | — |
| −2 | K160339 | Cardinal Health Isolation Gown | Cardinal Health200, LLC | 2016 | 2 |
| −1 | K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation… | Wildcat Ppe, LLC | 2021 | — |
| 0 (this device) | K212633 | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown -… | String King Lacrosse, LLC | 2021 | — |
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 FYC? 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 FYC device
- #1 K190306 AMD Ritmed AssureWear VersaGownscore 14.0 · 2 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 |
|---|---|---|---|
| * | K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full BackSummary page 4…EVICE Predicate Manufacturer: Wildcat PPE, LLC Predicate Trade Name: Wildcat PE Surgical Isolation Gown Full Back Predicate 510(k): K202310 No reference devices were used in this submission. IV. DEVICE DESCRIPTION Disposable, single-use isolation gown. The StringKi… | 2021 |
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 26 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K202310.
How does its category compare?
All FYC devicesFYC Gown, Isolation, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FYC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYC
95in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYC
3in 2025
MAUDE reports naming product code FYC, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 7 | 182 | 0 | 0 |
| 2022 | 10 | 229 | 0 | 0 |
| 2023 | 4 | 95 | 0 | 1 |
| 2024 | 1 | — | 2 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gowns are not intended for use in the operating room. The StringKing Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212633: Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212633
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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