510(k) · Cleared
ClearedBlack Nitrile Powder-Free Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northstar Healthcare Holdings · LZA Polymer Patient Examination Glove
Cleared on Jul 12, 2012 as substantially equivalent to K060724 (Smart Glove Corp. Sdn Bhd, 2006) after a 49-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Jul 12, 2012
- Review
- 49 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060724 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK060724 Powder Free Nitrile Examination Glove (Black and Gray)Smart Glove Corp. Sdn Bhd · 2006
- This deviceK121529 Black Nitrile Powder-Free Examination GlovesNorthstar Healthcare Holdings · 2012
- Descendant · cites it directly · 1 of its ownK143131 Powder Free Nitrile Patient Examination Glove, Black Colored…Kossan International Sdn Bhd · 2015
- Descendant · 2 generations on · 0 of its ownK213934 Pro Guard Nitrile Powder Free Examination GloveMedical Glove Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060724 | Powder Free Nitrile Examination Glove (Black and Gray) | Smart Glove Corp. Sdn Bhd | 2006 | — |
| 0 (this device) | K121529 | Black Nitrile Powder-Free Examination Gloves | Northstar Healthcare Holdings | 2012 | — |
| +1 | K143131 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | Kossan International Sdn Bhd | 2015 | — |
| +2 | K213934 | Pro Guard Nitrile Powder Free Examination Glove | Medical Glove Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K060724 | Powder Free Nitrile Examination Glove (Black and Gray)Summary page 1…evice Name Indication Clearance Company 510(k) Date K060724 Nitrite Powder The examination glove is a dispoale 7 May2006 Smart Free Examination d… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143131 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | 2015 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K143131 (Kossan International Sdn Bhd, 2015) 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. 2012, 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 examination glove is a disposable device intended for medical purposes 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/K121529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121529: Black Nitrile Powder-Free 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/K121529
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