510(k) · Cleared

Cleared

ProPel SG3™ Surgical Gown

K241214510(k) TraditionalCleared Sep 10, 2024133-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

Standard Textile Co., Inc. · FYA Gown, Surgical

Cleared on Sep 10, 2024 as substantially equivalent to K922753 (Standard Textile Co., Inc., 1993) after a 133-day review. Its family tree reaches back 1 generation to 1993.

Decided: Sep 10, 2024
Review: 133 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922753 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK922753 Compel XTRStandard Textile Co., Inc. · 1993
This deviceK241214 ProPel SG3™ Surgical GownStandard Textile Co., Inc. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922753	Compel XTR	Standard Textile Co., Inc.	1993	—
0 (this device)	K241214	ProPel SG3™ Surgical Gown	Standard Textile Co., Inc.	2024	—

FIG. 1 — Lineage of K241214, 1993–2024Source: 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
*	K922753	Compel XTR Summary page 5 …510(k) Number Predicate Device Name / Manufacturer Primary Predicate K922753 ComPel XTR/Standard Textile Co., Inc.  The predicate device has not been subject to a desig…	Standard Textile Co., Inc.	1993	—

Also cleared against K922753: 1 other device →

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 no recall.
1 other device also cites its predicate K922753.

How does its category compare?

All FYA devices

FYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?

ProPel SG3™ Surgical Gown is intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70.

The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Sterilization parameters are as follows:

Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time)

Item Number Gown Size Tag Color Gown Size

7565CC17 Yellow SM

7565CC16 Gold MD

7565CC15 Green LG

7565CC14 Red XL

7565CC13 Orange 2XL

7565CC12 Purple 3XL

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K241214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241214: ProPel SG3™ 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/K241214

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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