510(k) · Cleared
ClearedDisposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tangshan Lanhai Medical Supplies Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Aug 26, 2021 as substantially equivalent to K150340 (Hebei Hongsen Plastics Technology Co, Ltd., 2015) after a 153-day review. Its family tree reaches back 5 generations to 1999. 1 later device descends from it.
- Decided
- Aug 26, 2021
- Review
- 153 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K993247 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK993247 Nitrile Powder Free Patient Examination GlovesJda Intl., Inc. · 1999
- 4 generations backK082598 Powder Free Blue Patient Nitrile Examination GloveTangshan Zhonghong Pulin Group Co., Ltd. · 2009
- 3 generations backK121992 Powder-Free Nitrile Patient Examination Gloves, Blue ColorXinwei (Shandong) Plastic and Rubber Products Co., · 2012
- 2 generations backK131440 Powder Free Nitrile Patient Examination Gloves, BlueHebei Hongsen Plastics Technology Co, Ltd. · 2013
- 1 generation backK150340 POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES…Hebei Hongsen Plastics Technology Co, Ltd. · 2015
- This deviceK210898 Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)Tangshan Lanhai Medical Supplies Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK213604 ELAZ Nitrile Powder Free Examination GloveProtect Gloves Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213604ELAZ Nitrile Powder Free Examination GloveProtect Gloves Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993247 | Nitrile Powder Free Patient Examination Gloves | Jda Intl., Inc. | 1999 | — |
| −4 | K082598 | Powder Free Blue Patient Nitrile Examination Glove | Tangshan Zhonghong Pulin Group Co., Ltd. | 2009 | — |
| −3 | K121992 | Powder-Free Nitrile Patient Examination Gloves, Blue Color | Xinwei (Shandong) Plastic and Rubber Products Co., | 2012 | — |
| −2 | K131440 | Powder Free Nitrile Patient Examination Gloves, Blue | Hebei Hongsen Plastics Technology Co, Ltd. | 2013 | — |
| −1 | K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue)… | Hebei Hongsen Plastics Technology Co, Ltd. | 2015 | — |
| 0 (this device) | K210898 | Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) | Tangshan Lanhai Medical Supplies Co., Ltd. | 2021 | — |
| +1 | K213604 | ELAZ Nitrile Powder Free Examination Glove | Protect Gloves Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER…Summary page 5…7-1 Premarket Notification 510(k) Submission 510(k) Summary 510(k) Number: K150340 Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PL… | 2015 |
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 |
|---|---|---|---|
| K213604 | ELAZ Nitrile Powder Free Examination Glove | 2022 | 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 22 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K213604 (Protect Gloves Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K150340.
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 Nitrile Examination Gloves (Powder free, Purple-Blue, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210898 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210898: Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210898
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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