510(k) · Cleared
ClearedComfortGuard Surgical Isolation Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gri-Alleset, Inc. · FYC Gown, Isolation, Surgical
Cleared on Aug 26, 2021 after a 219-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 26, 2021
- Review
- 219 days
- Class
- Class II
- Product code
- FYC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 GRI-Alleset ComfortGuard™ Surgical Isolation Gown is a non-sterile disposable, single-use gown intended to protect both the health care worker and patients from the transfer of microorganisms, bodily fluids and particulate matter in moderate risk patient isolation situations. This gown in not intended for use in an operating room environment and should not be worn during surgical or invasive procedures or when there is a potential for a high risk of…
Read the full statement (111 words)
The GRI-Alleset ComfortGuard™ Surgical Isolation Gown is a non-sterile disposable, single-use gown intended to protect both the health care worker and patients from the transfer of microorganisms, bodily fluids and particulate matter in moderate risk patient isolation situations. This gown in not intended for use in an operating room environment and should not be worn during surgical or invasive procedures or when there is a potential for a high risk of contamination.
Additionally, the GRI-Alleset ComfortGuard™ Surgical Isolation Gown meets the requirements defined 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) for AAMI Level 3 barrier protection.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210131: ComfortGuard Surgical Isolation Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210131
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026