510(k) Report

510(k) · Cleared

Cleared

Imc Surgical Gowns

K052550510(k) TraditionalCleared Nov 17, 200562-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

Intl. Medsurg Connection, Inc. · FYA Gown, Surgical

Cleared on Nov 17, 2005 as substantially equivalent to K030364 (Deroyal Industries, Inc., 2003) after a 62-day review. Its family tree reaches back 1 generation to 2003. 25 later devices descend from it.

Decided
Nov 17, 2005
Review
62 days
Class
Class II
Product code
FYA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K030364 (2003). 25 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2010: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2018: 1 descendant cleared2022: 7 descendants cleared2021: 7 descendants cleared2024: 2 descendants cleared2023: 2 descendants cleared2026: 1 descendant clearedK030364 · Deroyal Gowns, Sterile, Non-Sterile · Deroyal Industries, Inc. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 5 descendants5 generations forward: 9 descendants6 generations forward: 4 descendants7 generations forward: 1 descendant K030364 · Deroyal Gowns, Sterile, Non-Sterile · Deroyal Industries, Inc. · 20030+5
  1. Root · 1 generation backK030364 Deroyal Gowns, Sterile, Non-SterileDeroyal Industries, Inc. · 2003
  2. This deviceK052550 Imc Surgical GownsIntl. Medsurg Connection, Inc. · 2005
  3. Descendant · cites it directly · 21 of its ownK100971 Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010
  4. Descendant · 2 generations on · 20 of its ownK120192 Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · Recalled
  5. Descendant · 3 generations on · 19 of its ownK172987 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001…Gmax Industries, Inc. · 2018
  6. Descendant · 4 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 · 5 generations on · 3 of its ownK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 12011: 12012: 12018: 12021: 72022: 72023: 22024: 22026: 1
2007high 7 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 25 · See all
  • K100971Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010 · cites it directly21descendants
  • K120192Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · 2 generations on20descendants
  • K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc. · 2018 · 3 generations on19descendants
  • K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021 · 4 generations on11descendants
  • K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K030364Deroyal Gowns, Sterile, Non-SterileDeroyal Industries, Inc.2003—
0 (this device)K052550Imc Surgical GownsIntl. Medsurg Connection, Inc.2005—
+1K100971Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd.2010—
+2K120192Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20121
+3K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc.2018—
+4K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.2021—
+5K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201010
201110
201210
201810
202170
202270
202320
202420
202610
FIG. 1 — Lineage of K052550, 2003–2026Source: 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
*K030364Deroyal Gowns, Sterile, Non-Sterile
Summary page 1
…Surgical Gown. Classification: Class II Predicate: Surgical Gowns, Reference K030364 owned by DeRoyal Industries. Description: Su…
Deroyal Industries, Inc.2003—

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K100971Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd.201021
K070431Welmed, Inc. Surgical GownsWelmed, Inc.20072
K102692SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with…Hangzhou Jincheng Medical Supplier Manufacture Co.20110

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.
  • Of its descendants, K100971 (Hangzhou Atek Medical & Textile Co., Ltd., 2010) has gone furthest, with 21 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.

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?

This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter.

This submission includes Surgical Gowns that will be sold both sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Indications for use as stated in the FDA summary.

More from Intl. Medsurg Connection, Inc.

2 FDA decisions under this applicant name. See the company

  • K050538Imc DrapesIntl. Medsurg Connection, Inc. · 2005

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/K052550 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052550: Imc 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/K052550

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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