510(k) · Cleared
Cleared3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M Reinforced Disposable Surgical Gown, 3M Disposable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company Corp · FYA Gown, Surgical
Cleared on Apr 14, 2011 as substantially equivalent to K080795 (Kimberly-Clark Corp., 2008) after a 322-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.
- Decided
- Apr 14, 2011
- Review
- 322 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080795 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK080795 Ultra Surgical Gown & Fluid Barrier Surgical GownKimberly-Clark Corp. · 2008
- This deviceK101468 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown…3M Company Corp · 2011
- Descendant · cites it directly · 0 of its ownK261811 PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED…PRIMED Medical Products, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…PRIMED Medical Products, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080795 | Ultra Surgical Gown & Fluid Barrier Surgical Gown | Kimberly-Clark Corp. | 2008 | — |
| 0 (this device) | K101468 | 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M… | 3M Company Corp | 2011 | — |
| +1 | K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug… | PRIMED Medical Products, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K080795 | Ultra Surgical Gown & Fluid Barrier Surgical GownSummary page 1…4040) Product Code: FYA Performance Standards: None Predicate Device: Kimberly Clark, Ultra Film-Reinforced Surgical Gown (K080795) Intended Use: The 3Mtm Basic Disposable Surgical Gowns, 3Mtm Disposable Surgical Gowns and 3M h HP Disposable Surgical Gowns are… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested… | 2026 | 0 |
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 FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The 3Mtm Basic Disposable Surgical Gowns, 3M~m Disposable Surgical Gowns and 3Mtm HP Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAMI Liquid Barrier Classification. The 3MTm Reinforced Disposable Surgical Gowns and 3Mtm HP Reinforced…
Read the full statement (173 words)
The 3Mtm Basic Disposable Surgical Gowns, 3M~m Disposable Surgical Gowns and 3Mtm HP Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAMI Liquid Barrier Classification.
The 3MTm Reinforced Disposable Surgical Gowns and 3Mtm HP Reinforced Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. The extra reinforced material is non-permeable and therefore provides a 100% barrier to liquids and blood- These gowns meet level 4 of the AAMI Liquid Barrier Classification within the critical areas of the gowns.*
*To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow.
These gowns are for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101468: 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M Reinforced Disposable Surgical Gown, 3M Disposable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101468
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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