510(k) · Cleared
ClearedKIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corporation · LZA Polymer Patient Examination Glove
Cleared on Jul 21, 2023 as substantially equivalent to K200072 (Kimberly-Clark Corporation, 2020) after a 102-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jul 21, 2023
- Review
- 102 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000323 (2000). 8 ancestors in all, the oldest K992162 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 5 generations backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- 4 generations backK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
- 3 generations backK083755 Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue…Siam Sempermed Corp., Ltd. · 2009
- 2 generations backK182241 Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for…Sri Trang Gloves (Thailand) Co., Ltd. · 2019
- 1 generation backK200072 KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use…Kimberly-Clark Corporation · 2020
- This deviceK231021 KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use…Kimberly-Clark Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −5 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| −4 | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with… | Siam Sempermed Corp., Ltd. | 2008 | — |
| −3 | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color… | Siam Sempermed Corp., Ltd. | 2009 | — |
| −2 | K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with… | Sri Trang Gloves (Thailand) Co., Ltd. | 2019 | — |
| −1 | K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with… | Kimberly-Clark Corporation | 2020 | — |
| 0 (this device) | K231021 | KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with… | Kimberly-Clark Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Summary page 6…Fentanyl and other opioid protection gloves OPJ Medical Gloves With Chemotherapy Labeling Claims 4. Predicate Device Information K200072 Powder-free Nitrile Exam Glove for use with Chemotherapy drugs and Fentanyl Product Code: LZC, LZA, QDO. 5. Device Descriptio… | 2020 |
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 23 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K200072.
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 nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.
In addition to routine examination glove’s intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231021: KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231021
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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