510(k) · Cleared
ClearedNitrile Examination Gloves (Model: ZMG1351)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Zonsen Medical Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Feb 18, 2022 as substantially equivalent to K211319 (Dezhou Purism Medical Technology Co., Ltd., 2021) after an 87-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- Feb 18, 2022
- Review
- 87 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K171422 (2018). No later device cites it as a predicate yet.
- Root · 3 generations backK171422 Disposable Powder Free Nitrile Examination Glove, White/ Blue/…Ever Global (Vietnam) Enterprise Corp · 2018
- 2 generations backK210057 Blue Nitrile Exam Glove, Powder FreeReal Star Medical Technology Co., Ltd. · 2021
- 1 generation backK211319 Purism Non-Sterile Powder Free Nitrile Examination GlovesDezhou Purism Medical Technology Co., Ltd. · 2021
- This deviceK213688 Nitrile Examination Gloves (Model: ZMG1351)Wuhan Zonsen Medical Products Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | Ever Global (Vietnam) Enterprise Corp | 2018 | — |
| −2 | K210057 | Blue Nitrile Exam Glove, Powder Free | Real Star Medical Technology Co., Ltd. | 2021 | — |
| −1 | K211319 | Purism Non-Sterile Powder Free Nitrile Examination Gloves | Dezhou Purism Medical Technology Co., Ltd. | 2021 | — |
| 0 (this device) | K213688 | Nitrile Examination Gloves (Model: ZMG1351) | Wuhan Zonsen Medical Products Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K211319 | Purism Non-Sterile Powder Free Nitrile Examination GlovesSummary page 4…. The gloves are non-sterile, powder free and are for single use only. 3. Predicate Device Identification 510(k) Number: K211319 Product Name: Purism Non-Sterile Powder Free Nitrile Examination Gloves Submitter/Manufacturer: Dezhou… | 2021 |
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 4 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand 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/K213688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213688: Nitrile Examination Gloves (Model: ZMG1351).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213688
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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