510(k) · Cleared

Cleared

Emm Surgical Gown - Spunlace with PE Layer

K111535510(k) TraditionalCleared Aug 26, 201185-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

Exact Medical Manufacturing, Inc. · FYA Gown, Surgical

Cleared on Aug 26, 2011 as substantially equivalent to K964142 (Medline Industries, Inc., 1997) after an 85-day review. Its family tree reaches back 1 generation to 1997.

Decided: Aug 26, 2011
Review: 85 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K964142 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997 · Recalled
This deviceK111535 Emm Surgical Gown - Spunlace with PE LayerExact Medical Manufacturing, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964142	Medline Disposable Surgical Drapes and Gowns	Medline Industries, Inc.	1997	3
0 (this device)	K111535	Emm Surgical Gown - Spunlace with PE Layer	Exact Medical Manufacturing, Inc.	2011	—

FIG. 1 — Lineage of K111535, 1997–2011Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K964142	Medline Disposable Surgical Drapes and Gowns Summary page 1 …. FYA, 21CFR878.4040, Surgical Apparel, Class 11 Classification Name Predicate Device Medline (Proxima) Surgical Gowns 510(k)964142 Device Description Exact Medical Manufacturing Surgical Gown-SP are single use, disposable surgica…	Medline Industries, Inc.	1997	3

Also cleared against K964142: 4 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?

Its one ancestor has a recall.
4 other devices also cite its predicate K964142.

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?

Exact Medical Manufacturing Surgical Gown - Spunlace wIPE Layer are sterile or non-sterile single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The Exact Medical Manufacturing Surgical Gown - Spunlace wIPE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111535 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111535: Emm Surgical Gown - Spunlace with PE Layer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111535

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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