510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Microcool Breathable High Performance Surgical Gowns

K103406510(k) TraditionalCleared Dec 23, 201034-day reviewClass II21 CFR 878.4040Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kimberly-Clark Corp. · FYA Gown, Surgical

Cleared on Dec 23, 2010 as substantially equivalent to K091357 (Kimberly-Clark Corp., 2009) after a 34-day review. Its family tree reaches back 2 generations to 1998. 7 later devices descend from it. It has been recalled 2 times.

Decided
Dec 23, 2010
Review
34 days
Class
Class II
Product code
FYA
Recalls
2
Predicates
1

Its longest line of descent runs back 2 generations to K981393 (1998). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2019: 1 descendant cleared2016: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant clearedK981393 · Microcool Surgical Gown · Kimberly-Clark Corp. · 1998K091357 · Microcool Surgical Gown, Breathable High Performance KC400 · Kimberly-Clark Corp. · 2009 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants K091357 · Microcool Surgical Gown, Breathable High Performance KC400 · Kimberly-Clark Corp. · 2009 · recalledK981393 · Microcool Surgical Gown · Kimberly-Clark Corp. · 19980
  1. Root · 2 generations backK981393 Microcool Surgical GownKimberly-Clark Corp. · 1998
  2. 1 generation backK091357 Microcool Surgical Gown, Breathable High Performance KC400Kimberly-Clark Corp. · 2009 · Recalled
  3. This deviceK103406 Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp. · 2010
  4. Descendant · cites it directly · 6 of its ownK140539 Aero Blue Performance Surgical GownKimberly-Clark Corporation · 2014
  5. Descendant · 2 generations on · 4 of its ownK153255 Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 2016
  6. Descendant · 3 generations on · 2 of its ownK200522 AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc. · 2020
  7. Descendant · 4 generations on · 0 of its ownK260725 BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V. · 2026
  8. Descendant · 4 generations on · 0 of its ownK210688 AERO CHROME* Select Breathable Performance Surgical Gown, AERO…O&M Halyard, Inc. · 2021

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2014: 12016: 12017: 12019: 12020: 12021: 12026: 1
2014high 1 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K140539Aero Blue Performance Surgical GownKimberly-Clark Corporation · 2014 · cites it directly6descendants
  • K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 2016 · 2 generations on4descendants
  • K200522AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc. · 2020 · 3 generations on2descendants
  • K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V. · 2026 · 4 generations on0descendants
  • K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable…O&M Halyard, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K981393Microcool Surgical GownKimberly-Clark Corp.1998—
−1K091357Microcool Surgical Gown, Breathable High Performance KC400Kimberly-Clark Corp.20092
0 (this device)K103406Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp.2010—
+1K140539Aero Blue Performance Surgical GownKimberly-Clark Corporation2014—
+2K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc.2016—
+3K200522AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc.2020—
+4K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.2026—
+4K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line…O&M Halyard, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201610
201710
201910
202010
202110
202610
FIG. 1 — Lineage of K103406, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211422 Level 2 Standard Surgical Gown, Level 3…score 20.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K091357Microcool Surgical Gown, Breathable High Performance KC400
Summary page 1
…The predicate device for this Kimberly-Clark*MicroCool Predicate Devices Breathable High Performance Surgical Gown submission is K091357, the Kimberly-Clark MicroCool Surgical Gown, Breathable High Performance, KC400 Device The Micr…
Kimberly-Clark Corp.20092

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140539Aero Blue Performance Surgical GownKimberly-Clark Corporation20146

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 5, 2012Class IIZ-0257-2013Packaging process controlPackage seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Jul 5, 2012Class IIZ-0258-2013Packaging process controlPackage seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 11.1 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K140539 (Kimberly-Clark Corporation, 2014) has gone furthest, with 6 descendants of its own.

How does its category compare?

All FYA devices

FYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · FYA

4in 2025

2007: 62008: 42009: 62010: 42011: 82012: 42013: 22014: 52015: 32016: 32017: 42018: 22019: 52020: 72021: 172022: 242023: 122024: 52025: 42026 (partial year): 9
2007high 24 (2022) · low 2 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FYA

210in 2025

2007: 110 days median2008: 207 days median2009: 98 days median2010: 128 days median2011: 141 days median2012: 202 days median2014: 120 days median2015: 275 days median2016: 155 days median2017: 111 days median2019: 105 days median2020: 114 days median2021: 163 days median2022: 177 days median2023: 190 days median2024: 163 days median2025: 210 days median2026 (partial year): 198 days median
2007high 275 (2015) · low 98 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FYA

1in 2025

2007: 22010: 22012: 12014: 9, 9 Class I2018: 12020: 402021: 112022: 22023: 12025: 12026 (partial year): 2
2007high 40 (2020) · low 0 (2008)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · FYA

14in 2025

2007: 82008: 32009: 182010: 92011: 162012: 432013: 712014: 422015: 592016: 432017: 662018: 982019: 382020: 312021: 152022: 42023: 122024: 272025: 14
2007high 98 (2018) · low 3 (2008)2025

MAUDE reports naming product code FYA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611028
2008420703
2009698018
2010412829
20118141016
20124202143
20132—071
201451209 (9)42
20153275059
20163155043
20174111066
20182—198
20195105038
202071144031
2021171631115
20222417724
202312190112
20245163027
20254210114
202691982—

What is it indicated for?

The Kimberly-Clark t MicroCool t Surgical Gowns, are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The MicroCool t Surgical Gown meets the Level 4 requirements of the AAMI Liquid Barrier classifications.

The Kimberly-Clark t MicroCool t Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Indications for use as stated in the FDA summary.

More from Kimberly-Clark Corp.

104 FDA decisions under this applicant name. See the company

  • K140963Kimguard Smart-Fold Sterilization WrapKimberly-Clark Corp. · 2014
  • K141294U by Kotex Security Unscented Menstrual TamponsKimberly-Clark Corp. · 2014
  • K131879KC 300 Surgical MaskKimberly-Clark Corp. · 20131 recall
  • K131841Kimberly-Clark Lavender Nitrile Powder-Free Exam GloveKimberly-Clark Corp. · 2013
  • K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. · 20135 Class I recalls

Recent decisions in FYA

The FYA category page

  • K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle &…Principle & Will Co., Ltd. · 2026
  • K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd. · 2026
  • K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery Studio · 2026
  • K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES) · 2026
  • K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V. · 2026

https://510kreport.com/device/K103406 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103406: Microcool Breathable High Performance Surgical Gowns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103406

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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