510(k) · Cleared

Cleared

SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace Gowns (Reinfo

K102692510(k) TraditionalCleared Mar 11, 2011172-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 Jincheng Medical Supplier Manufacture Co. · FYA Gown, Surgical

Cleared on Mar 11, 2011 as substantially equivalent to K052550 (Intl. Medsurg Connection, Inc., 2005) and 1 other predicate after a 172-day review. Its family tree reaches back 3 generations to 2003.

Decided: Mar 11, 2011
Review: 172 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K030364 (2003). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK030364 Deroyal Gowns, Sterile, Non-SterileDeroyal Industries, Inc. · 2003
2 generations backK052550 Imc Surgical GownsIntl. Medsurg Connection, Inc. · 2005
1 generation backK070431 Welmed, Inc. Surgical GownsWelmed, Inc. · 2007
This deviceK102692 SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns…Hangzhou Jincheng Medical Supplier Manufacture Co. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K030364	Deroyal Gowns, Sterile, Non-Sterile	Deroyal Industries, Inc.	2003	—
−2	K052550	Imc Surgical Gowns	Intl. Medsurg Connection, Inc.	2005	—
−1	K070431	Welmed, Inc. Surgical Gowns	Welmed, Inc.	2007	—
0 (this device)	K102692	SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular…	Hangzhou Jincheng Medical Supplier Manufacture Co.	2011	—

FIG. 1 — Lineage of K102692, 2003–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K211422 Level 2 Standard Surgical Gown, Level 3…score 20.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K052550	Imc Surgical Gowns Summary page 1 …ary: June 22, 2010 Name of Device: Surgical Gown Classification Name: Gown, Surgical Product Code: FYA Regulation Number: 807.4040 Predicate Device Information: (1) K052550, "International Medsurp Connection Surgical Gowns (IMC Gowns)", manufactured by "International Medsurp Connection Surgical…	Intl. Medsurg Connection, Inc.	2005	—
*	K070431	Welmed, Inc. Surgical Gowns Summary page 1 …edsurp Connection Surgical Gowns (IMC Gowns)", manufactured by "International Medsurp Connection Surgical Gown Inc" located in Schaumburg, Illinois. (2) K07043 1, Welmed Surgical Gowns, manufactured by Welmed, Inc. located in Grayslake, Illinois. Device description: The Jincheng Su…	Welmed, Inc.	2007	—

Also cleared against K052550: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 8 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
None of the 3 ancestors has a recall.
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. 2011, this device’s year, is highlighted.

FDA decisions per year · FYA

4in 2025

2007high 24 (2022) · low 2 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FYA

210in 2025

2007high 275 (2015) · low 98 (2009)2026

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

Recalls per year · FYA

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	110	2	8
2008	4	207	0	3
2009	6	98	0	18
2010	4	128	2	9
2011	8	141	0	16
2012	4	202	1	43
2013	2	—	0	71
2014	5	120	9 (9)	42
2015	3	275	0	59
2016	3	155	0	43
2017	4	111	0	66
2018	2	—	1	98
2019	5	105	0	38
2020	7	114	40	31
2021	17	163	11	15
2022	24	177	2	4
2023	12	190	1	12
2024	5	163	0	27
2025	4	210	1	14
2026	9	198	2	—

What is it indicated for?

Gowns provided as 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.

https://510kreport.com/device/K102692 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102692: SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace Gowns (Reinfo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102692

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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