510(k) · Cleared

Recalled · Class II · 2020

Cardinal Health Non-Reinforced Surgical Gown

K170762510(k) TraditionalCleared Jun 9, 201788-day reviewClass II21 CFR 878.4040Recalls 17

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardinal Health200, LLC · FYA Gown, Surgical

Cleared on Jun 9, 2017 as substantially equivalent to K020593 (Allegiance Healthcare Corp., 2002) after an 88-day review. Its family tree reaches back 1 generation to 2002. 19 later devices descend from it. It has been recalled 17 times.

Decided: Jun 9, 2017
Review: 88 days
Class: Class II
Product code: FYA
Recalls: 17
Predicates: 1

Its longest line of descent runs back 1 generation to K020593 (2002). 19 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK020593 Convertors SMS Polyolefin GownAllegiance Healthcare Corp. · 2002 · Recalled
This deviceK170762 Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC · 2017
Descendant · cites it directly · 5 of its ownK190950 Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline…Medline Industries, Inc. · 2019 · Recalled
Descendant · cites it directly · 2 of its ownK212591 Disposable Surgical GownSuzhou Janee Medical Technology Co., Ltd. · 2022
Descendant · cites it directly · 2 of its ownK211509 Surgical GownHubei Wanli Protective Products Co., Ltd. · 2021
Descendant · cites it directly · 2 of its ownK173847 Disposable Ultra Reinforced Surgical GownXiantao Rayxin Medical Products Co., Ltd. · 2019
Descendant · 2 generations on · 1 of its ownK222999 Surgical GownHubei Woozon Healthcare Co., Ltd. · 2023

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2019high 5 (2022) · low 0 (2020)2026

Most influential descendants

Showing 5 of 19 · See all

K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown…Medline Industries, Inc. · 2019 · cites it directly5descendants
K212591Disposable Surgical GownSuzhou Janee Medical Technology Co., Ltd. · 2022 · cites it directly2descendants
K211509Surgical GownHubei Wanli Protective Products Co., Ltd. · 2021 · cites it directly2descendants
K173847Disposable Ultra Reinforced Surgical GownXiantao Rayxin Medical Products Co., Ltd. · 2019 · cites it directly2descendants
K222999Surgical GownHubei Woozon Healthcare Co., Ltd. · 2023 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020593	Convertors SMS Polyolefin Gown	Allegiance Healthcare Corp.	2002	23
0 (this device)	K170762	Cardinal Health Non-Reinforced Surgical Gown	Cardinal Health200, LLC	2017	—
+1	K190950	Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3…	Medline Industries, Inc.	2019	2
+1	K212591	Disposable Surgical Gown	Suzhou Janee Medical Technology Co., Ltd.	2022	—
+1	K211509	Surgical Gown	Hubei Wanli Protective Products Co., Ltd.	2021	—
+1	K173847	Disposable Ultra Reinforced Surgical Gown	Xiantao Rayxin Medical Products Co., Ltd.	2019	—
+2	K222999	Surgical Gown	Hubei Woozon Healthcare Co., Ltd.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	2	0
2021	4	0
2022	5	0
2023	4	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K170762, 2002–2026Source: 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

Get a 510(k) Report

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
*	K020593	Convertors SMS Polyolefin Gown Summary page 4 …roduct Code: FYA Classification Name: Surgical Gown Predicate Device: Convertors® SMS Polyolefin Standard Gown (K020593) 03/17 69 of 568…	Allegiance Healthcare Corp.	2002	23

Also cleared against K020593: 1 other device →

What descends from it? (19)

See all 19

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K190950	Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown…	Medline Industries, Inc.	2019	5
K212591	Disposable Surgical Gown	Suzhou Janee Medical Technology Co., Ltd.	2022	2
K211509	Surgical Gown	Hubei Wanli Protective Products Co., Ltd.	2021	2
K173847	Disposable Ultra Reinforced Surgical Gown	Xiantao Rayxin Medical Products Co., Ltd.	2019	2
K251860	Copioumed AAMI 3 Surgical Gown	Copioumed International, Inc.	2026	0
K212718	Surgical gowns	Xiantao Dingcheng Non-Woven Product Co., Ltd.	2022	0
K202532	Disposable Surgical Gowns	Anhui Medpurest Medical Technology Co.,Ltd	2021	0
K210510	Disposable Surgical Gown	Shandong Zhushi Pharmaceutical Group Co., Ltd.	2021	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 11, 2020	Class II	Z-1020-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1033-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1015-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1019-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1021-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1031-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1038-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1039-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1018-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1032-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1003-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1007-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1016-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1028-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1029-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1030-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Class II	Z-1037-2020	Vendor change control	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

The 5 latest of 17 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K190950 (Medline Industries, Inc., 2019) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K020593.

How does its category compare?

All FYA devices

FYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?

Cardinal Health™ Non-Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Cardinal Health™ Non-Reinforced Surgical Gowns are single use, disposable medical devices; provided sterile and non-sterile.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K170762 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170762: Cardinal Health Non-Reinforced 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/K170762

Report an extraction error

Are you the manufacturer?

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