510(k) · Cleared

Cleared

Master & Frank Surgical Gowns (Sterile)

K012186510(k) TraditionalCleared Dec 7, 2001148-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

Master & Frank Ent. Co., Ltd. · FYA Gown, Surgical

Cleared on Dec 7, 2001 as substantially equivalent to K964142 (Medline Industries, Inc., 1997) after a 148-day review. Its family tree reaches back 1 generation to 1997. 23 later devices descend from it.

Decided: Dec 7, 2001
Review: 148 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K964142 (1997). 23 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997 · Recalled
This deviceK012186 Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd. · 2001
Descendant · cites it directly · 21 of its ownK100971 Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010
Descendant · 2 generations on · 20 of its ownK120192 Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · Recalled
Descendant · 3 generations on · 19 of its ownK172987 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001…Gmax Industries, Inc. · 2018
Descendant · 4 generations on · 11 of its ownK211422 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021
Descendant · 5 generations on · 3 of its ownK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2007high 7 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 23 · See all

K100971Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010 · cites it directly21descendants
K120192Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · 2 generations on20descendants
K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc. · 2018 · 3 generations on19descendants
K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021 · 4 generations on11descendants
K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021 · 5 generations on3descendants

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)	K012186	Master & Frank Surgical Gowns (Sterile)	Master & Frank Ent. Co., Ltd.	2001	—
+1	K100971	Atek Surgical Gowns	Hangzhou Atek Medical & Textile Co., Ltd.	2010	—
+2	K120192	Disposable Surgical Gowns	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	2012	1
+3	K172987	Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)	Gmax Industries, Inc.	2018	—
+4	K211422	Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3…	Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.	2021	—
+5	K212869	Disposable Surgical Gown, Disposable Reinforced Surgical Gown	Fugou County Shenxiang Manufacturing Co., Ltd.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2010	1	0
2012	1	0
2018	1	0
2021	7	0
2022	7	0
2023	2	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K012186, 1997–2026Source: 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
*	K964142	Medline Disposable Surgical Drapes and Gowns Summary page 1 …6577 Mr. Frank Wu (General Manag:r) Master & Frank Surgical Gowns(Sterile) Sterile Surgical Gowns GOWN, SURGICAL Class 11 Medline Disposable Surgicil Drapes & Gowns ( K964142) Master & Frank Surgical Gowns (Sterile), is manufactured from non-woven fabric. This surgical Gown is supplied sterile and for…	Medline Industries, Inc.	1997	3

Also cleared against K964142: 4 other devices →

What descends from it? (23)

See all 23

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

Number	Device	Applicant	Decided	Descendants
K100971	Atek Surgical Gowns	Hangzhou Atek Medical & Textile Co., Ltd.	2010	21
K062479	Joykey Surgical Gowns (Sterile)	Joykey Industryial, Ltd.	2007	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 a recall.
Of its descendants, K100971 (Hangzhou Atek Medical & Textile Co., Ltd., 2010) has gone furthest, with 21 descendants of its own.
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.

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?

Master & Frank Surgical Gowns (Sterile) are single use article of surgical apparel that is intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012186 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012186: Master & Frank Surgical Gowns (Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012186

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026