510(k) · Cleared
ClearedEmm High Performance Surgical Gown with Aami Liquid Barrier Level IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exact Medical Manufacturing, Inc. · FYA Gown, Surgical
Cleared on Jun 12, 2012 as substantially equivalent to K992514 (Allegiance Healthcare Corp., 1999) after a 158-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 12, 2012
- Review
- 158 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992514 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992514 Convertors Breathable Surgical GownsAllegiance Healthcare Corp. · 1999
- This deviceK120045 Emm High Performance Surgical Gown with Aami Liquid Barrier Level IVExact Medical Manufacturing, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992514 | Convertors Breathable Surgical Gowns | Allegiance Healthcare Corp. | 1999 | — |
| 0 (this device) | K120045 | Emm High Performance Surgical Gown with Aami Liquid Barrier Level IV | Exact Medical Manufacturing, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K992514 | Convertors Breathable Surgical GownsSummary page 1…Codes and IFYA, 21 CFR878.4040, Surgical Apparel Classification Name Predicate Device Convertors SmartGown K992514 Device Description Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV… | 1999 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV are sterile or non-sterile single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Sterile surgical gowns are to be sold directly to users after EtO sterilization and validated to ISO…
Read the full statement (104 words)
Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV are sterile or non-sterile single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Sterile surgical gowns are to be sold directly to users after EtO sterilization and validated to ISO 11135-1:2007.
The Exact Medical Manufacturing Surgical Gowns with AAMI Level IV Liquid Barrier are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120045: Emm High Performance Surgical Gown with Aami Liquid Barrier Level IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120045
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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