510(k) · Cleared
ClearedDisposable Medical Nitrile Examination Gloves (Model:XYS-001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anhui Xinyisheng Medical Technology Co.,Ltd · LZA Polymer Patient Examination Glove
Cleared on Dec 9, 2021 as substantially equivalent to K192333 (Jr Engineering & Medical Technologies (M) Sdn. Bhd., 2020) after a 58-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Dec 9, 2021
- Review
- 58 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022548 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK022548 Medtexx Blue Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd. · 2002
- 2 generations backK172930 mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd. · 2018
- 1 generation backK192333 Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
- This deviceK213371 Disposable Medical Nitrile Examination Gloves (Model:XYS-001)Anhui Xinyisheng Medical Technology Co.,Ltd · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022548 | Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves | Latexx Manufacturing Sdn.Bhd. | 2002 | — |
| −2 | K172930 | mCare Powder-free Blue Nitrile Examination Gloves | Mercator Medical (Thailand), Ltd. | 2018 | — |
| −1 | K192333 | Blue Nitrile Examination Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020 | — |
| 0 (this device) | K213371 | Disposable Medical Nitrile Examination Gloves (Model:XYS-001) | Anhui Xinyisheng Medical Technology Co.,Ltd | 2021 | — |
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 LZA? 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 LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K192333 | Blue Nitrile Examination Gloves Powder FreeSummary page 4…Regulation Class: Class I Panel: General Hospital Product Code: LZA 3. Predicate Device 510(K) number: K192333 Device Name: Blue Nitrile Examination Gloves Powder Free Manufacturer: JR Engineering & Medical… | 2020 |
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.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- 23 other devices also cite its predicate K192333.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, 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 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213371: Disposable Medical Nitrile Examination Gloves (Model:XYS-001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213371
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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