510(k) · Cleared
ClearedIsolation Gown (S, M, L, XL, XXL (Yellow, Blue))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allmed Medical (Hubei) Protective Products Co., Ltd. · FYC Gown, Isolation, Surgical
Cleared on Aug 12, 2022 as substantially equivalent to K160339 (Cardinal Health200, LLC, 2016) after a 128-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Aug 12, 2022
- Review
- 128 days
- Class
- Class II
- Product code
- FYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952116 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK952116 Cover GownAmerican Threshold Industries, Inc. · 1995
- 1 generation backK160339 Cardinal Health Isolation GownCardinal Health200, LLC · 2016 · Recalled
- This deviceK221027 Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))Allmed Medical (Hubei) Protective Products Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K160339 | Cardinal Health Isolation GownSummary page 4…fication Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital C. Predicate device: K160339 Cardinal Health™ Isolation Gown Cardinal Health 200, LLC D. Indications for use of the device:… | 2016 |
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 27 years and passes through 3 companies; a new generation was cleared every 20.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K160339.
How does its category compare?
All FYC devicesFYC Gown, Isolation, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical device provided non-sterile.
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/K221027 · printed Nov 3, 2026
Cite this page
510(k) Report. “K221027: Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K221027
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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