510(k) · Cleared
ClearedPOWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hebei Hongsen Plastics Technology Co, Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jun 18, 2015 as substantially equivalent to K131440 (Hebei Hongsen Plastics Technology Co, Ltd., 2013) after a 127-day review. Its family tree reaches back 4 generations to 1999. 13 later devices descend from it.
- Decided
- Jun 18, 2015
- Review
- 127 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K993247 (1999). 13 later devices descend from it, 9 citing it directly.
- Root · 4 generations backK993247 Nitrile Powder Free Patient Examination GlovesJda Intl., Inc. · 1999
- 3 generations backK082598 Powder Free Blue Patient Nitrile Examination GloveTangshan Zhonghong Pulin Group Co., Ltd. · 2009
- 2 generations backK121992 Powder-Free Nitrile Patient Examination Gloves, Blue ColorXinwei (Shandong) Plastic and Rubber Products Co., · 2012
- 1 generation backK131440 Powder Free Nitrile Patient Examination Gloves, BlueHebei Hongsen Plastics Technology Co, Ltd. · 2013
- This deviceK150340 POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES…Hebei Hongsen Plastics Technology Co, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK211457 Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)Ammex Corporation · 2021
- Descendant · cites it directly · 1 of its ownK212497 Nitrile Examination Glove (Powder free, Blue)Jiangsu Jinlian Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK210898 Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)Tangshan Lanhai Medical Supplies Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK202356 Powder free Nitrile Examination Gloves (Blue, Violet Blue, White…Kanglongda Vietnam Protection Technology Company Limited · 2021
- Descendant · 2 generations on · 0 of its ownK241970 Powder Free Nitrile Examination Gloves (Blue), Tested for Use with…Kanglongda Vietnam Protection Technology Company Limited · 2024
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K211457Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)Ammex Corporation · 2021 · cites it directly1descendant
- K212497Nitrile Examination Glove (Powder free, Blue)Jiangsu Jinlian Medical Technology Co., Ltd. · 2021 · cites it directly1descendant
- K210898Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)Tangshan Lanhai Medical Supplies Co., Ltd. · 2021 · cites it directly1descendant
- K202356Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)Kanglongda Vietnam Protection Technology Company Limited · 2021 · cites it directly1descendant
- K241970Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs…Kanglongda Vietnam Protection Technology Company Limited · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993247 | Nitrile Powder Free Patient Examination Gloves | Jda Intl., Inc. | 1999 | — |
| −3 | K082598 | Powder Free Blue Patient Nitrile Examination Glove | Tangshan Zhonghong Pulin Group Co., Ltd. | 2009 | — |
| −2 | K121992 | Powder-Free Nitrile Patient Examination Gloves, Blue Color | Xinwei (Shandong) Plastic and Rubber Products Co., | 2012 | — |
| −1 | K131440 | Powder Free Nitrile Patient Examination Gloves, Blue | Hebei Hongsen Plastics Technology Co, Ltd. | 2013 | — |
| 0 (this device) | K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue)… | Hebei Hongsen Plastics Technology Co, Ltd. | 2015 | — |
| +1 | K211457 | Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) | Ammex Corporation | 2021 | — |
| +1 | K212497 | Nitrile Examination Glove (Powder free, Blue) | Jiangsu Jinlian Medical Technology Co., Ltd. | 2021 | — |
| +1 | K210898 | Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) | Tangshan Lanhai Medical Supplies Co., Ltd. | 2021 | — |
| +1 | K202356 | Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) | Kanglongda Vietnam Protection Technology Company Limited | 2021 | — |
| +2 | K241970 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Kanglongda Vietnam Protection Technology Company Limited | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K131440 | Powder Free Nitrile Patient Examination Gloves, BlueSummary page 5…. Predicate Device Identification E2-1 510(k) Number: k131440 Product Name: Powder free Patient Examination Gloves, Blue Color Manufacturer: Hebei HongSen Plastics Technology Co., L… | 2013 |
What descends from it? (13)
See all 139 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211457 | Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) | 2021 | 1 |
| K212497 | Nitrile Examination Glove (Powder free, Blue) | 2021 | 1 |
| K210898 | Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) | 2021 | 1 |
| K202356 | Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) | 2021 | 1 |
| K213029 | Nitrile Examination Gloves (Powder free, Blue) | 2021 | 0 |
| K211586 | Nitrile Examination Gloves (Blue, Violet) | 2021 | 0 |
| K211581 | Disposable Nitrile Examination Gloves (Powder free, Blue) | 2021 | 0 |
| K210578 | Medical Nitrile Examination Gloves (Power free, Blue) | 2021 | 0 |
| K202402 | Nitrile Examination Gloves (Blue, Violet Blue, White) | 2021 | 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 16 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K211457 (Ammex Corporation, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K131440.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice 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/K150340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150340: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150340
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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