510(k) Report

510(k) · Cleared

Cleared

Atek Surgical Gowns

K100971510(k) TraditionalCleared Sep 27, 2010172-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

Hangzhou Atek Medical & Textile Co., Ltd. · FYA Gown, Surgical

Cleared on Sep 27, 2010 as substantially equivalent to K052550 (Intl. Medsurg Connection, Inc., 2005) and 1 other predicate after a 172-day review. Its family tree reaches back 2 generations to 1997. 21 later devices descend from it.

Decided
Sep 27, 2010
Review
172 days
Class
Class II
Product code
FYA
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K964142 (1997). 4 ancestors in all. 21 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 1 other ancestor2012: 1 descendant cleared2018: 1 descendant cleared2022: 7 descendants cleared2021: 7 descendants cleared2024: 2 descendants cleared2023: 2 descendants cleared2026: 1 descendant clearedK964142 · Medline Disposable Surgical Drapes and Gowns · Medline Industries, Inc. · 1997 · recalledK012186 · Master & Frank Surgical Gowns (Sterile) · Master & Frank Ent. Co., Ltd. · 20011995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 5 descendants4 generations forward: 9 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant K012186 · Master & Frank Surgical Gowns (Sterile) · Master & Frank Ent. Co., Ltd. · 2001K964142 · Medline Disposable Surgical Drapes and Gowns · Medline Industries, Inc. · 1997 · recalled0+5
  1. Root · 2 generations backK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997 · Recalled
  2. 1 generation backK012186 Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd. · 2001
  3. This deviceK100971 Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010
  4. Descendant · cites it directly · 20 of its ownK120192 Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · Recalled
  5. Descendant · 2 generations on · 19 of its ownK172987 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001…Gmax Industries, Inc. · 2018
  6. Descendant · 3 generations on · 11 of its ownK211422 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021
  7. Descendant · 4 generations on · 3 of its ownK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021
  8. Descendant · 4 generations on · 2 of its ownK212861 Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co., Ltd. · 2021

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2012: 12018: 12021: 72022: 72023: 22024: 22026: 1
2012high 7 (2021) · low 0 (2013)2026

Most influential descendants

Showing 5 of 21 · See all
  • K120192Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · cites it directly20descendants
  • K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc. · 2018 · 2 generations on19descendants
  • K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021 · 3 generations on11descendants
  • K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021 · 4 generations on3descendants
  • K212861Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co., Ltd. · 2021 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K964142Medline Disposable Surgical Drapes and GownsMedline Industries, Inc.19973
−1K012186Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd.2001—
0 (this device)K100971Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd.2010—
+1K120192Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20121
+2K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc.2018—
+3K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.2021—
+4K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.2021—
+4K212861Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co., Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201810
202170
202270
202320
202420
202610
FIG. 1 — Lineage of K100971, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K052550Imc Surgical Gowns
Summary page 3
…u m b er______ Hangzhou ATek IMC Surgical International Medsurg K052550 Medical and Gowns Connections, Inc. Textile Surgical Mas…
Intl. Medsurg Connection, Inc.2005—
*K012186Master & Frank Surgical Gowns (Sterile)
Summary page 3
…Gowns Connections, Inc. Textile Surgical Master & Frank Master and Frank K012186 Gowns Surgical Gowns Enterprises, Co. LTD _______________…
Master & Frank Ent. Co., Ltd.2001—

Also cleared against K052550: 2 other devices →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K120192Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd.201220

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?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K120192 (Weihai Hongyu Nonwoven Fabric Products Co., Ltd., 2012) has gone furthest, with 20 descendants of its own.
  • 2 other devices also cite its predicate K052550.

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?

Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.

Gowns provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEIVs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.

The following disposable surgical gown types and model numbers are included in this submission

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K052550

2 other devices cite the same predicate.

  • K102692SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace…Hangzhou Jincheng Medical Supplier Manufacture Co. · 2011
  • K070431Welmed, Inc. Surgical GownsWelmed, Inc. · 2007

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/K100971 · printed Nov 4, 2026

Cite this page

510(k) Report. “K100971: Atek Surgical Gowns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100971

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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