510(k) · Cleared
ClearedNitrile Exam Gloves, Powder-Free, Color Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Poseidon Plastic Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on May 23, 2000 after a 46-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 23, 2000
- Review
- 46 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK001128 Nitrile Exam Gloves, Powder-Free, Color BlueShanghai Poseidon Plastic Products Co., Ltd. · 2000
- Descendant · cites it directly · 0 of its ownK070862 Powder Free Nitrile Examination Gloves (Blue, Wihte)Purtech Cleanroom Products Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK060147 Powder Free Nitrile Examination Gloves, BlueHongye Plastic Products Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK052877 Powder Free Nitrile Blue Textured Examination GloveSyntex Healthcare Products Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK014077 Powder Free (Blue) Nitrile Patient Examination GlovesShijiazhuang Great Vision Plastic Products Co., LT · 2002
Most influential descendants
Showing 4 of 4 · See all- K070862Powder Free Nitrile Examination Gloves (Blue, Wihte)Purtech Cleanroom Products Co., Ltd. · 2007 · cites it directly0descendants
- K060147Powder Free Nitrile Examination Gloves, BlueHongye Plastic Products Co., Ltd. · 2006 · cites it directly0descendants
- K052877Powder Free Nitrile Blue Textured Examination GloveSyntex Healthcare Products Co., Ltd. · 2005 · cites it directly0descendants
- K014077Powder Free (Blue) Nitrile Patient Examination GlovesShijiazhuang Great Vision Plastic Products Co., LT · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001128 | Nitrile Exam Gloves, Powder-Free, Color Blue | Shanghai Poseidon Plastic Products Co., Ltd. | 2000 | — |
| +1 | K070862 | Powder Free Nitrile Examination Gloves (Blue, Wihte) | Purtech Cleanroom Products Co., Ltd. | 2007 | — |
| +1 | K060147 | Powder Free Nitrile Examination Gloves, Blue | Hongye Plastic Products Co., Ltd. | 2006 | — |
| +1 | K052877 | Powder Free Nitrile Blue Textured Examination Glove | Syntex Healthcare Products Co., Ltd. | 2005 | — |
| +1 | K014077 | Powder Free (Blue) Nitrile Patient Examination Gloves | Shijiazhuang Great Vision Plastic Products Co., LT | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
4 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?
- Of its descendants, K070862 (Purtech Cleanroom Products Co., Ltd., 2007) 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.
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 | — |
https://510kreport.com/device/K001128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K001128: Nitrile Exam Gloves, Powder-Free, Color Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001128
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026