510(k) · Cleared
ClearedNitrile Examination Gloves, Dual Color Black-Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanxi Hongjin Plastic Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Oct 20, 2023 as substantially equivalent to K201857 (Careplus (M) Sdn Bhd, 2021) after a 58-day review. Its family tree reaches back 5 generations to 2007.
- Decided
- Oct 20, 2023
- Review
- 58 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K062764 (2007). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK062764 Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)…Kossan Latex Industries (M)Sdn Bhd · 2007
- 4 generations backK111772 Powder Free Nitrile Patient Examination Glove, Blue Colored and…Kossan Latex Industries (M)Sdn Bhd · 2011
- 3 generations backK123469 Powder Free Nitrile Patient Examination Glove, Blue and White…Wear Safe (Malaysia) Sdn Bhd - Facility II · 2013
- 2 generations backK142862 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 2015
- 1 generation backK201857 Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd · 2021
- This deviceK232550 Nitrile Examination Gloves, Dual Color Black-BlueShanxi Hongjin Plastic Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K062764 | Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue… | Kossan Latex Industries (M)Sdn Bhd | 2007 | — |
| −4 | K111772 | Powder Free Nitrile Patient Examination Glove, Blue Colored and White… | Kossan Latex Industries (M)Sdn Bhd | 2011 | — |
| −3 | K123469 | Powder Free Nitrile Patient Examination Glove, Blue and White Colored… | Wear Safe (Malaysia) Sdn Bhd - Facility II | 2013 | — |
| −2 | K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | Careplus (M) Sdn Bhd | 2015 | — |
| −1 | K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | Careplus (M) Sdn Bhd | 2021 | — |
| 0 (this device) | K232550 | Nitrile Examination Gloves, Dual Color Black-Blue | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-BlueSummary page 5…el: General Hospital Device Class: Class I 3. Predicate Device Information: Careplus (M) SDN BHD. Powder Free Nitrile Examination Glove Black and Dual Color White-Blue (K201857) 4. Device Description: Nitrile Examination Gloves, Dual Color Black-Blue are Class I Patient Examination Gloves. The glove is m… | 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 16 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232550: Nitrile Examination Gloves, Dual Color Black-Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232550
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