510(k) Report

510(k) · Cleared

Cleared

Ultra Surgical Gown & Fluid Barrier Surgical Gown

K080795510(k) AbbreviatedCleared Sep 3, 2008167-day reviewClass II21 CFR 878.4040

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 Sep 3, 2008 after a 167-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.

Decided
Sep 3, 2008
Review
167 days
Class
Class II
Product code
FYA
Recalls
None
Predicates
0

18 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2016: 1 descendant cleared2017: 2 descendants cleared2019: 1 descendant cleared2026: 3 descendants cleared2015: 1 descendant cleared2012: 1 descendant cleared2023: 2 descendants cleared2025: 1 descendant cleared2021: 2 descendants cleared2022: 2 descendants cleared20052010201520202025
  1. This deviceK080795 Ultra Surgical Gown & Fluid Barrier Surgical GownKimberly-Clark Corp. · 2008
  2. Descendant · cites it directly · 8 of its ownK102652 Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns…Gri Medical & Electronic Technology Co., Ltd. · 2011
  3. Descendant · 2 generations on · 7 of its ownK121152 Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd. · 2012
  4. Descendant · 3 generations on · 3 of its ownK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021
  5. Descendant · cites it directly · 2 of its ownK182172 Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown…Medline Industries, Inc. · 2019 · Recalled
  6. Descendant · cites it directly · 1 of its ownK163191 ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd. · 2017

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12015: 12016: 12017: 22019: 12021: 22022: 22023: 22025: 12026: 3
2011high 3 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 18 · See all
  • K102652Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced…Gri Medical & Electronic Technology Co., Ltd. · 2011 · cites it directly8descendants
  • K121152Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd. · 2012 · 2 generations on7descendants
  • K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021 · 3 generations on3descendants
  • K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline…Medline Industries, Inc. · 2019 · cites it directly2descendants
  • K163191ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd. · 2017 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K080795Ultra Surgical Gown & Fluid Barrier Surgical GownKimberly-Clark Corp.2008—
+1K102652Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric…Gri Medical & Electronic Technology Co., Ltd.2011—
+2K121152Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd.2012—
+3K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.2021—
+1K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown…Medline Industries, Inc.20191
+1K163191ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201510
201610
201720
201910
202120
202220
202320
202510
202630
FIG. 1 — Lineage of K080795, 2008–2026Source: 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? (2)

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
*—KIMGUARD Surgical Gowns
Named without a submission number
—
*—SPUNGUARD Surgical Gowns
Named without a submission number
—

What descends from it? (18)

See all 18

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102652Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced…Gri Medical & Electronic Technology Co., Ltd.20118
K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline…Medline Industries, Inc.20192
K163191ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd.20171
K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd.20161
K1014683M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M Reinforced…3M Company Corp20111

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, K102652 (Gri Medical & Electronic Technology Co., Ltd., 2011) has gone furthest, with 8 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. 2008, 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* ULTRA Surgical Gowns and ULTRA Film-Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The ULTRA Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications, and the ULTRA Film-Reinforced Surgical Gowns meet Level 4 of the AAMI Liquid Barrier classifications.

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/K080795 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080795: Ultra Surgical Gown & Fluid Barrier 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/K080795

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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