510(k) · Cleared
ClearedDisposable Nitrile Examination Gloves (Powder free, Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leping Shengde Medical Technology Company Limited · LZA Polymer Patient Examination Glove
Cleared on Oct 28, 2021 as substantially equivalent to K150340 (Hebei Hongsen Plastics Technology Co, Ltd., 2015) after a 160-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Oct 28, 2021
- Review
- 160 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K993247 (1999). No later device cites it as a predicate yet.
- 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 deviceK211581 Disposable Nitrile Examination Gloves (Powder free, Blue)Leping Shengde Medical Technology Company Limited · 2021
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) | K211581 | Disposable Nitrile Examination Gloves (Powder free, Blue) | Leping Shengde Medical Technology Company Limited | 2021 | — |
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…e examiner’s hands to prevent contamination between patient and examiner. 5. Predicate Device Identification Primary Predicate Device 510(k) Number: K150340 Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TEC… | 2015 |
| † | K210898 | Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) | 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 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.
- 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, 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/K211581 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211581: Disposable Nitrile Examination Gloves (Powder free, Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211581
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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