510(k) · Cleared

Cleared

Barrier Surgical Gowns

K050786510(k) SpecialCleared May 9, 200542-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

Molnlycke Health Care · FYA Gown, Surgical

Cleared on May 9, 2005 as substantially equivalent to K760903 (Surgikos, Inc., 1976) and 3 other predicates after a 42-day review. Its family tree reaches back 1 generation to 1976.

Decided: May 9, 2005
Review: 42 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K760903 (1976). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK760903 Barrier Fabric 450 Surgical GownsSurgikos, Inc. · 1976
This deviceK050786 Barrier Surgical GownsMolnlycke Health Care · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K760903	Barrier Fabric 450 Surgical Gowns	Surgikos, Inc.	1976	—
0 (this device)	K050786	Barrier Surgical Gowns	Molnlycke Health Care	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1994	1	0
1999	1	0

FIG. 1 — Lineage of K050786, 1976–2005Source: 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? (4)

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
*	K760903	Barrier Fabric 450 Surgical Gowns Summary page 2 …cations under which they are currently marketed. Description Predicate 5 10(k) BARRIER® Standard and Standard K760903 Fabric Reinforced Surgical Gowns BARRIER® Extra and Ultra Protection K760903 G ow ns…	Surgikos, Inc.	1976	—
*	K932731	Barrier* Extra Protection Plus Surgical Gown Summary page 2 …_ _ _ _ _ _ _ _ _ _ _ BARRIER® Extra and Ultra Protection K93273 1 Plus Surgical Gowns BARRIER® Surgical Gown II and K920996 BARRIER® Surgical Gown 11 , Fabric…	Johnson & Johnson Medical, Inc.	1994	—
*	K920996	Barrier Surgical Gown with Symetry Fabric Summary page 2 …_ _ _ _ BARRIER® Extra and Ultra Protection K93273 1 Plus Surgical Gowns BARRIER® Surgical Gown II and K920996 BARRIER® Surgical Gown 11 , Fabric Reinforced _ _ _…	Johnson & Johnson Medical, Inc.	1992	—
*	K990395	Barrier Surgical Gowns Summary page 2 …_ _ _ _ _ _ _ _ _ _ _ _ BARRIER® Fluid Protection Plus K990395 Surgical Gowns _ _ _ _ _ _ _…	Johnson & Johnson Medical, Div. of Ethicon, Inc.	1999	—

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?

None of the 4 ancestors has a recall.

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

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?

BARRIER® surgical gowns are intended for single use to be worn by the Surgical Team Members in the operating room during surgical procedures to protect both the patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050786 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050786: Barrier Surgical Gowns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050786

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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