510(k) · Cleared
ClearedSurgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gmax Industries, Inc. · FYA Gown, Surgical
Cleared on Jul 13, 2018 as substantially equivalent to K043585 (Medline Industries, Inc., 2005) and 1 other predicate after a 289-day review. Its family tree reaches back 4 generations to 1997. 19 later devices descend from it.
- Decided
- Jul 13, 2018
- Review
- 289 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964142 (1997). 7 ancestors in all. 19 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997 · Recalled
- 3 generations backK012186 Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd. · 2001
- 2 generations backK100971 Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010
- 1 generation backK120192 Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · Recalled
- This deviceK172987 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001…Gmax Industries, Inc. · 2018
- Descendant · cites it directly · 11 of its ownK211422 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK212861 Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK202844 Medical Surgical GownsBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK231510 Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown…Xiantao Zhibo Non-Woven Products Co., Ltd. · 2023
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021 · cites it directly11descendants
- K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021 · 2 generations on3descendants
- K212861Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co., Ltd. · 2021 · 2 generations on2descendants
- K202844Medical Surgical GownsBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021 · cites it directly2descendants
- K231510Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)Xiantao Zhibo Non-Woven Products Co., Ltd. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964142 | Medline Disposable Surgical Drapes and Gowns | Medline Industries, Inc. | 1997 | 3 |
| −3 | K012186 | Master & Frank Surgical Gowns (Sterile) | Master & Frank Ent. Co., Ltd. | 2001 | — |
| −2 | K100971 | Atek Surgical Gowns | Hangzhou Atek Medical & Textile Co., Ltd. | 2010 | — |
| −1 | K120192 | Disposable Surgical Gowns | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2012 | 1 |
| 0 (this device) | K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | Gmax Industries, Inc. | 2018 | — |
| +1 | K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3… | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | 2021 | — |
| +2 | K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Fugou County Shenxiang Manufacturing Co., Ltd. | 2021 | — |
| +2 | K212861 | Surgical Gown, Reinforced Surgical Gown | Wuhan Zonsen Medical Products Co., Ltd. | 2021 | — |
| +1 | K202844 | Medical Surgical Gowns | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021 | — |
| +3 | K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 7 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K043585 | Medline Surgical GownsSummary page 7…2 AE3001 XL Poly-reinforced 2 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K043585 Product Name: Medline EclipseTM Surgical Gown Manufacturer: MEDLINE INDUSTRIES, INC. Predicate Device 2 510… | 2005 |
| * | K120192 | Disposable Surgical GownsSummary page 7…510(k) Number: K043585 Product Name: Medline EclipseTM Surgical Gown Manufacturer: MEDLINE INDUSTRIES, INC. Predicate Device 2 510(k) Number: K120192 Product Name: Disposable Surgical Gowns Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co., Ltd. 6. Non-Clini… | 2012 |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K211422 (Jiangsu Medplus Non-Woven Manufacturer Co., Ltd., 2021) has gone furthest, with 11 descendants of its own.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FYA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FYA
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYA
1in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · FYA
14in 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?
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification.…
Read the full statement (132 words)
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification.
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AG series surgical gowns met the requirements for Level 3 classification.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172987
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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