510(k) · Cleared
ClearedNon-Sterile Powder-Free, Blue Nitrile Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sgmp Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Apr 20, 2000 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 20, 2000
- Review
- 34 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK000868 Non-Sterile Powder-Free, Blue Nitrile Examination GlovesSgmp Co., Ltd. · 2000
- Descendant · cites it directly · 1 of its ownK072400 Non-Sterile, Powder-Free, Black Nitrile Examination GlovesSgmp Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK101646 Non-Sterile, Powder Free Black Nitrile Examination Gloves with…Sgmp Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK062138 Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free…Molnlycke Health Care, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK042879 Non-Sterile Powder-Free Blue Nitrile Examination Gloves, with…Sgmp Co., Ltd. · 2005
Most influential descendants
Showing 4 of 4 · See all- K072400Non-Sterile, Powder-Free, Black Nitrile Examination GlovesSgmp Co., Ltd. · 2008 · cites it directly1descendant
- K101646Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry FlavorSgmp Co., Ltd. · 2010 · 2 generations on0descendants
- K062138Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene…Molnlycke Health Care, Inc. · 2006 · cites it directly0descendants
- K042879Non-Sterile Powder-Free Blue Nitrile Examination Gloves, with Vanilla ScentingSgmp Co., Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000868 | Non-Sterile Powder-Free, Blue Nitrile Examination Gloves | Sgmp Co., Ltd. | 2000 | — |
| +1 | K072400 | Non-Sterile, Powder-Free, Black Nitrile Examination Gloves | Sgmp Co., Ltd. | 2008 | — |
| +2 | K101646 | Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor | Sgmp Co., Ltd. | 2010 | — |
| +1 | K062138 | Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free… | Molnlycke Health Care, Inc. | 2006 | — |
| +1 | K042879 | Non-Sterile Powder-Free Blue Nitrile Examination Gloves, with Vanilla Scenting | Sgmp Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 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, K072400 (Sgmp Co., Ltd., 2008) has gone furthest, with 1 descendant 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/K000868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000868: Non-Sterile Powder-Free, Blue Nitrile Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000868
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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