510(k) · Cleared
ClearedPlus Medical Chemotherapy Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Nanhai Plus Medical Co, Ltd. · FYA Gown, Surgical
Cleared on May 4, 2022 after a 392-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 4, 2022
- Review
- 392 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and…
Read the full statement (280 words)
Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Plus Medical Chemotherapy Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
Plus Medical Chemotherapy Gown has been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12 Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact. Testing data is provided per test procedure ASTM F739-12, the following 12 chemotherapy drugs has no breakthrough at the Standardized Breakthrough Rate of 0.1ug/cm2/minute, up to 480 minutes.
Test Chemotherapy Drugs Average Standardized Breakthrough Time
Carmustine (BCNU) [3.3mg/ml] >480mins
Cisplatin [1.0mg/ml] >480mins
Cyclophosphamide (Cytoxan) [20.0mg/ml] >480mins
Dacarbazine [10.0mg/ml] >480mins
Doxorubicin HCI [2.0mg/ml] >480mins
Etoposide [20.0mg/ml] >480mins
Fluorouracil [SO0mg/ml] >480mins
Methotrexate [25mg/ml] >480mins
Mitomycin C [0.5mg/ml] >480mins
Paclitaxel [6.0mg/ml] >480mins
Thio Tepa [10mg/ml] >480mins
Vincristine Sulfate [1.0mg/ml] >480mins
*No permeation was detected at either the minimum detectable permeation or 0.1ug/cm2/minute.
When chemotherapy drugs are present, gown selection should be based on the specific type(s) of chemicals used. Users are recommended to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211036: Plus Medical Chemotherapy Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211036
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026