510(k) · Cleared
ClearedPRIMAGARD Isolation Gown (AAMI PB70 Level 3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primed Medical Products, Inc. · FYC Gown, Isolation, Surgical
Cleared on Nov 4, 2016 as substantially equivalent to K981393 (Kimberly-Clark Corp., 1998) after a 269-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Nov 4, 2016
- Review
- 269 days
- Class
- Class II
- Product code
- FYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981393 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK981393 Microcool Surgical GownKimberly-Clark Corp. · 1998
- This deviceK160361 PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK232849 Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard…Owens & Minor (O&M) Halyard, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK212717 Paneffort AAMI Level 3 Isolation GownPaneffort, LLC · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981393 | Microcool Surgical Gown | Kimberly-Clark Corp. | 1998 | — |
| 0 (this device) | K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | Primed Medical Products, Inc. | 2016 | — |
| +1 | K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer… | Owens & Minor (O&M) Halyard, Inc. | 2024 | — |
| +1 | K212717 | Paneffort AAMI Level 3 Isolation Gown | Paneffort, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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 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.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FYC devicesFYC Gown, Isolation, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
PRIMAGARD Level 3 Isolation Gowns, are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for healthcare personnel and patients from transfer of microorganisms, body fluids, and particulate material. The PRIMAGARD Isolation Gowns, meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only. PRIMAGARD Isolation Gowns (AAMI…
Read the full statement (142 words)
PRIMAGARD Level 3 Isolation Gowns, are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for healthcare personnel and patients from transfer of microorganisms, body fluids, and particulate material.
The PRIMAGARD Isolation Gowns, meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.
PRIMAGARD Isolation Gowns (AAMI PB70 level 3) are available in 5 models as below:
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tape Tab Neck Closure (Universal, XL),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Hook and Loop Closure (Universal, XL),
- PRIMAGARD Overhead Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal, XL),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tie Neck Closure (Universal, XL)
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/K160361 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160361: PRIMAGARD Isolation Gown (AAMI PB70 Level 3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160361
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026