510(k) Report

510(k) · Cleared

Cleared

50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown

K192290510(k) TraditionalCleared Apr 30, 2020251-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

Xuchang Zhengde Environstar Medical Products Co., Ltd. · FYA Gown, Surgical

Cleared on Apr 30, 2020 after a 251-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.

Decided
Apr 30, 2020
Review
251 days
Class
Class II
Product code
FYA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2022: 6 descendants cleared2021: 2 descendants cleared2020: 1 descendant cleared2023: 3 descendants cleared2026: 1 descendant cleared2020202220242026
  1. This deviceK192290 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with…Xuchang Zhengde Environstar Medical Products Co., Ltd. · 2020
  2. Descendant · cites it directly · 5 of its ownK202706 Surgical Gown (Sterile), Surgical Gown (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2020
  3. Descendant · cites it directly · 3 of its ownK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021
  4. Descendant · 2 generations on · 0 of its ownK253003 Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical…Hubei Xinxin Non-Woven Co., Ltd. · 2026
  5. Descendant · 2 generations on · 0 of its ownK222456 High Protection Surgical Gown3A Medical Products Co., Ltd. · 2023
  6. Descendant · 2 generations on · 0 of its ownK221559 Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3Stringking · 2023

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2020: 12021: 22022: 62023: 32026: 1
2020high 6 (2022) · low 0 (2024)2026

Most influential descendants

Showing 5 of 13 · See all
  • K202706Surgical Gown (Sterile), Surgical Gown (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2020 · cites it directly5descendants
  • K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021 · cites it directly3descendants
  • K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd. · 2026 · 2 generations on0descendants
  • K222456High Protection Surgical Gown3A Medical Products Co., Ltd. · 2023 · 2 generations on0descendants
  • K221559Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3Stringking · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K19229050g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g…Xuchang Zhengde Environstar Medical Products Co., Ltd.2020—
+1K202706Surgical Gown (Sterile), Surgical Gown (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.2020—
+1K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.2021—
+2K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown…Hubei Xinxin Non-Woven Co., Ltd.2026—
+2K222456High Protection Surgical Gown3A Medical Products Co., Ltd.2023—
+2K221559Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3Stringking2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202120
202260
202330
202610
FIG. 1 — Lineage of K192290, 2020–2026Source: 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 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. #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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K202706Surgical Gown (Sterile), Surgical Gown (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20205
K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.20213
K213893Comfort Gown, Safewear GownXuchang Zhengde Environstar Medical Products Co., Ltd.20220
K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS…Winner Medical Co., Ltd.20220
K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown…Dukal Corporation20220

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, K202706 (B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd., 2020) has gone furthest, with 5 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. 2020, 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?

Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, SMS Standard Surgical Gown and SMS Surgical Gown with Reinforcement met the requirements for Level 3 classification; BVB Surgical Gown and BVB Splicing Surgical Gown met the requirements for Level 4 classification.

Indications for use as stated in the FDA 510(k) statement.

More from Xuchang Zhengde Environstar Medical…

2 FDA decisions under this applicant name. See the company

  • K213893Comfort Gown, Safewear GownXuchang Zhengde Environstar Medical Products Co., Ltd. · 2022

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/K192290 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192290: 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing 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/K192290

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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