510(k) · Cleared
ClearedNitrile Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Runheng Medical Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jun 22, 2022 as substantially equivalent to K211515 (Beijing Reagent Latex Products Co., Ltd., 2021) after a 205-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it.
- Decided
- Jun 22, 2022
- Review
- 205 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022548 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK022548 Medtexx Blue Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd. · 2002
- 3 generations backK172930 mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd. · 2018
- 2 generations backK192333 Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
- 1 generation backK211515 Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. · 2021
- This deviceK213739 Nitrile Examination GlovesHangzhou Runheng Medical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK230633 APOLLO ADVANTAGE Nitrile Examination GlovesDell Corning Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K230633APOLLO ADVANTAGE Nitrile Examination GlovesDell Corning Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022548 | Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves | Latexx Manufacturing Sdn.Bhd. | 2002 | — |
| −3 | K172930 | mCare Powder-free Blue Nitrile Examination Gloves | Mercator Medical (Thailand), Ltd. | 2018 | — |
| −2 | K192333 | Blue Nitrile Examination Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020 | — |
| −1 | K211515 | Nitrile Examination Gloves | Beijing Reagent Latex Products Co., Ltd. | 2021 | — |
| 0 (this device) | K213739 | Nitrile Examination Gloves | Hangzhou Runheng Medical Co., Ltd. | 2022 | — |
| +1 | K230633 | APOLLO ADVANTAGE Nitrile Examination Gloves | Dell Corning Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 |
|---|---|---|---|
| * | K211515 | Nitrile Examination GlovesSummary page 4…nt examination glove Regulatory Class: Class I Product code: LZA Review Panel: General Hospital III Predicate Devices 510(k) Number: K211515 Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered p… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230633 | APOLLO ADVANTAGE Nitrile Examination Gloves | 2023 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K230633 (Dell Corning Corporation, 2023) has gone furthest, with 0 descendants of its own.
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 purpose that are 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/K213739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213739: Nitrile 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/K213739
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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