510(k) · Cleared
ClearedPowder Free Nitrile Patient Examination Gloves, 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 Sep 25, 2013 as substantially equivalent to K121992 (Xinwei (Shandong) Plastic and Rubber Products Co.,, 2012) after a 128-day review. Its family tree reaches back 3 generations to 1999. 15 later devices descend from it.
- Decided
- Sep 25, 2013
- Review
- 128 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993247 (1999). 15 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK993247 Nitrile Powder Free Patient Examination GlovesJda Intl., Inc. · 1999
- 2 generations backK082598 Powder Free Blue Patient Nitrile Examination GloveTangshan Zhonghong Pulin Group Co., Ltd. · 2009
- 1 generation backK121992 Powder-Free Nitrile Patient Examination Gloves, Blue ColorXinwei (Shandong) Plastic and Rubber Products Co., · 2012
- This deviceK131440 Powder Free Nitrile Patient Examination Gloves, BlueHebei Hongsen Plastics Technology Co, Ltd. · 2013
- Descendant · cites it directly · 13 of its ownK150340 POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES…Hebei Hongsen Plastics Technology Co, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK211457 Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)Ammex Corporation · 2021
- Descendant · 2 generations on · 1 of its ownK212497 Nitrile Examination Glove (Powder free, Blue)Jiangsu Jinlian Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK210898 Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)Tangshan Lanhai Medical Supplies Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK202356 Powder free Nitrile Examination Gloves (Blue, Violet Blue, White…Kanglongda Vietnam Protection Technology Company Limited · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K150340POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER…Hebei Hongsen Plastics Technology Co, Ltd. · 2015 · cites it directly13descendants
- K211457Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)Ammex Corporation · 2021 · 2 generations on1descendant
- K212497Nitrile Examination Glove (Powder free, Blue)Jiangsu Jinlian Medical Technology Co., Ltd. · 2021 · 2 generations on1descendant
- K210898Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)Tangshan Lanhai Medical Supplies Co., Ltd. · 2021 · 2 generations on1descendant
- K202356Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)Kanglongda Vietnam Protection Technology Company Limited · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993247 | Nitrile Powder Free Patient Examination Gloves | Jda Intl., Inc. | 1999 | — |
| −2 | K082598 | Powder Free Blue Patient Nitrile Examination Glove | Tangshan Zhonghong Pulin Group Co., Ltd. | 2009 | — |
| −1 | K121992 | Powder-Free Nitrile Patient Examination Gloves, Blue Color | Xinwei (Shandong) Plastic and Rubber Products Co., | 2012 | — |
| 0 (this device) | 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 | — |
| +2 | K211457 | Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) | Ammex Corporation | 2021 | — |
| +2 | K212497 | Nitrile Examination Glove (Powder free, Blue) | Jiangsu Jinlian Medical Technology Co., Ltd. | 2021 | — |
| +2 | K210898 | Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) | Tangshan Lanhai Medical Supplies Co., Ltd. | 2021 | — |
| +2 | K202356 | Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) | Kanglongda Vietnam Protection Technology Company Limited | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K121992 | Powder-Free Nitrile Patient Examination Gloves, Blue ColorSummary page 1…I Regulation Number: 21 CFR 880.6250 Panel: General Hospital Product Code: LZA 5.5 Predicate Device Information: (1) K121992, "Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue Color", manufactured by "Xinwei (Shandong) Plastic and Rubbe… | 2012 |
What descends from it? (15)
See all 152 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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150340 (Hebei Hongsen Plastics Technology Co, Ltd., 2015) has gone furthest, with 13 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. 2013, 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 Titan powder free nitrile patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. It has blue color and is sold as non sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131440: Powder Free Nitrile Patient Examination Gloves, Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131440
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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