510(k) · Cleared

Cleared

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

K162442510(k) TraditionalCleared Dec 12, 2016103-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

Gri Medical & Electrical Technology Co., Ltd. · FYA Gown, Surgical

Cleared on Dec 12, 2016 as substantially equivalent to K080795 (Kimberly-Clark Corp., 2008) after a 103-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.

Decided: Dec 12, 2016
Review: 103 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K080795 (2008). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK080795 Ultra Surgical Gown & Fluid Barrier Surgical GownKimberly-Clark Corp. · 2008
This deviceK162442 ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown…Gri Medical & Electrical Technology Co., Ltd. · 2016
Descendant · cites it directly · 0 of its ownK230707 Skypro, Surgical Gown 6021Skypro Medical Supplies Company · 2023

Most influential descendants

Showing 1 of 1 · See all

K230707Skypro, Surgical Gown 6021Skypro Medical Supplies Company · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K080795	Ultra Surgical Gown & Fluid Barrier Surgical Gown	Kimberly-Clark Corp.	2008	—
0 (this device)	K162442	ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500	Gri Medical & Electrical Technology Co., Ltd.	2016	—
+1	K230707	Skypro, Surgical Gown 6021	Skypro Medical Supplies Company	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K162442, 2008–2023Source: 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
*	K080795	Ultra Surgical Gown & Fluid Barrier Surgical Gown Summary page 5 …General and plastic surgery Product Code: FYA Predicate Device: Kimberly-Clark ULTRA Surgical Gown (K080795) Traditional 510(k) Page: 1 ComfortGuard Surgical…	Kimberly-Clark Corp.	2008	—

Also cleared against K080795: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K230707	Skypro, Surgical Gown 6021	Skypro Medical Supplies Company	2023	0

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.
Of its descendants, K230707 (Skypro Medical Supplies Company, 2023) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K080795.

How does its category compare?

All FYA devices

FYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?

ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare…

Read the full statement (132 words)

ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162442 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162442: ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162442

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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