510(k) · Cleared
ClearedNitrile Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yingxiang Glove Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Oct 14, 2021 as substantially equivalent to K171422 (Ever Global (Vietnam) Enterprise Corp, 2018) after a 115-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Oct 14, 2021
- Review
- 115 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K171422 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK171422 Disposable Powder Free Nitrile Examination Glove, White/ Blue/…Ever Global (Vietnam) Enterprise Corp · 2018
- This deviceK211914 Nitrile Patient Examination GlovesYingxiang Glove Products Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK222527 Nitrile Patient Examination GlovePingan Medical Products Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK222534 Nitrile Patient Examination GloveJiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | Ever Global (Vietnam) Enterprise Corp | 2018 | — |
| 0 (this device) | K211914 | Nitrile Patient Examination Gloves | Yingxiang Glove Products Co., Ltd. | 2021 | — |
| +1 | K222527 | Nitrile Patient Examination Glove | Pingan Medical Products Co., Ltd. | 2022 | — |
| +1 | K222534 | Nitrile Patient Examination Glove | Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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 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 |
|---|---|---|---|
| * | K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink ColorSummary page 5…ink Color Page 1 of 8 Nitrile Patient Examination Gloves FDA 510(k) Files 510(k) number: K171422 5.0 Indications for Use The Nitrile Patient Examination Gloves are disposable devices intended for medical purposes that are wo… | 2018 |
What descends from it? (2)
2 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?
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 Nitrile Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner’s hands to prevent contamination between patient and examiner.
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/K211914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211914: Nitrile Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211914
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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