510(k) · Cleared
ClearedKS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koon Seng Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Feb 22, 2018 as substantially equivalent to K161422 (Wrp Asia Pacific Sdn. Bhd., 2016) after a 307-day review. Its family tree reaches back 4 generations to 2004. 5 later devices descend from it.
- Decided
- Feb 22, 2018
- Review
- 307 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042805 (2004). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 3 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 2 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 1 generation backK161422 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2016
- This deviceK171171 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile…Koon Seng Sdn Bhd · 2018
- Descendant · cites it directly · 4 of its ownK190403 Disposable Powder Free Nitrile Examination Glove, White, Tested for…Ever Global (Vietnam) Enterprise Corporation · 2019
- Descendant · 2 generations on · 3 of its ownK193555 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corp · 2020
- Descendant · 3 generations on · 1 of its ownK244034 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corporation · 2025
- Descendant · 4 generations on · 0 of its ownK252244 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK230662 Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy…Zhonghong Pulin Medical Products Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K190403Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With…Ever Global (Vietnam) Enterprise Corporation · 2019 · cites it directly4descendants
- K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corp · 2020 · 2 generations on3descendants
- K244034Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corporation · 2025 · 3 generations on1descendant
- K252244Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corporation · 2025 · 4 generations on0descendants
- K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl…Zhonghong Pulin Medical Products Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −3 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −2 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −1 | K161422 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2016 | — |
| 0 (this device) | K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for… | Koon Seng Sdn Bhd | 2018 | — |
| +1 | K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With… | Ever Global (Vietnam) Enterprise Corporation | 2019 | — |
| +2 | K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corp | 2020 | — |
| +3 | K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corporation | 2025 | — |
| +4 | K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corporation | 2025 | — |
| +3 | K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs… | Zhonghong Pulin Medical Products Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K161422 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for…Summary page 5…ate Device): Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs previously cleared under 510(k) K161422 (product code LZA, LZC) 4. Device Description: KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Che… | 2016 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With… | 2019 | 4 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K190403 (Ever Global (Vietnam) Enterprise Corporation, 2019) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K161422.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
A powder-free patient 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection…
Read the full statement (321 words)
A powder-free patient 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection time in Minutes
1. Carmustine (BCNU), 3.3 mg/ml 22.6
2. Cisplatin, 1.0 mg/ml > 240
3. Cyclophosphamide (Cytoxan), 20.0 mg/ml >240
4. Dacarbazine (DTIC), 10.0 mg/ml > 240
5. Doxorubicin Hydrochloride, 2.0 mg/ml > 240
6. Etoposide (Toposar), 20.0 mg/ml >240
7. Fluorouracil, 50.0 mg/ml > 240
8. Methotrexate, 25 mg/ml > 240
9. Paclitaxel (Taxol), 6.0 mg/ml > 240
10. Thiotepa, 10.0 mg/ml 14.0
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
Carmustine (BCNU), 3.3 mg/ml 22.6 minutes
Thiotepa, 10.0 mg/ml 14.0 minutes
A powder-free patient 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes
1. Carmustine (BCNU), 3.3 mg/ml 14.8
2. Cisplatin, 1.0 mg/ml > 240
3. Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240
4. Dacarbazine (DTIC), 10.0 mg/ml > 240
5. Doxorubicin Hydrochloride, 2.0 mg/ml > 240
6. Etoposide (Toposar), 20.0 mg/ml >240
7. Fluorouracil, 50.0 mg/ml > 240
8. Methotrexate, 25 mg/ml > 240
9. Paclitaxel (Taxol), 6.0 mg/ml > 240
10. Thiotepa, 10.0 mg/ml 35.2
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
Carmustine (BCNU), 3.3 mg/ml 14.8 minutes
Thiotepa, 10.0 mg/ml 35.2 minutes
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171171: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171171
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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