510(k) · Cleared
ClearedBlockade Surgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · FYA Gown, Surgical
Cleared on Apr 28, 2016 after a 416-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Apr 28, 2016
- Review
- 416 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK150598 Blockade Surgical GownMedline Industries, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK201351 Maxima Surgical GownElevate Textiles · 2022
Most influential descendants
Showing 1 of 1 · See all- K201351Maxima Surgical GownElevate Textiles · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K150598 | Blockade Surgical Gown | Medline Industries, Inc. | 2016 | — |
| +1 | K201351 | Maxima Surgical Gown | Elevate Textiles | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K201351 | Maxima Surgical Gown | 2022 | 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?
- Of its descendants, K201351 (Elevate Textiles, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Blockade reusable surgical gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material. The Blockade reusable surgical gown is provided non-sterile. Sterilization parameters are as follows: * Prevac Steam Sterilization - 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)…
Read the full statement (134 words)
The Blockade reusable surgical gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material.
The Blockade reusable surgical gown is provided non-sterile. Sterilization parameters are as follows:
* Prevac Steam Sterilization - 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)
Medline Item Numbers / gown color / liq. barrier protection / gown size
MDTGBS3CL / Ceil / AAMI Level 3 / Large
MDTGBS3CXL / Ceil / AAMI Level 3 / X-Large
MDTGBS3C2X / Ceil / AAMI Level 3 / XX-Large
MDTGBS3JL / Jade / AAMI Level 3 / Large
MDTGBS3JXL / Jade / AAMI Level 3 / X-Large
MDTGBS3J2X / Jade / AAMI Level 3 / XX-Large
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K150598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150598: Blockade Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150598
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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