510(k) · Cleared
ClearedNitrile Examination Gloves Powder Free (Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Great Eco Glove Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Sep 2, 2021 as substantially equivalent to K172642 (Central Medicare Sdn Bhd, 2017) after a 163-day review. Its family tree reaches back 2 generations to 2015.
- Decided
- Sep 2, 2021
- Review
- 163 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K143247 (2015). No later device cites it as a predicate yet.
- Root · 2 generations backK143247 Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and…Central Medicare Sdn Bhd · 2015
- 1 generation backK172642 Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd · 2017
- This deviceK210868 Nitrile Examination Gloves Powder Free (Blue)Great Eco Glove Sdn. Bhd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White… | Central Medicare Sdn Bhd | 2015 | — |
| −1 | K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd | 2017 | — |
| 0 (this device) | K210868 | Nitrile Examination Gloves Powder Free (Blue) | Great Eco Glove Sdn. Bhd. | 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 |
|---|---|---|---|
| * | K172642 | Orange Non Sterile Powder Free Nitrile Examination GlovesSummary page 4…rade Name Orange Non Sterile Powder Free Nitrile Examination Gloves 510 (k) Number K172642 Product Code LZA Classification 21 CFR 880.6250… | 2017 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K172642.
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?
Disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210868 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210868: Nitrile Examination Gloves Powder Free (Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210868
Report an extraction error
Are you the manufacturer?
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