510(k) · Cleared
ClearedDisposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Global (Vietnam) Enterprise Corporation · LZA Polymer Patient Examination Glove
Cleared on Sep 6, 2019 as substantially equivalent to K171171 (Koon Seng Sdn Bhd, 2018) after a 199-day review. Its family tree reaches back 5 generations to 2004. 4 later devices descend from it.
- Decided
- Sep 6, 2019
- Review
- 199 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042805 (2004). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 4 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 3 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 2 generations backK161422 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2016
- 1 generation backK171171 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile…Koon Seng Sdn Bhd · 2018
- This deviceK190403 Disposable Powder Free Nitrile Examination Glove, White, Tested for…Ever Global (Vietnam) Enterprise Corporation · 2019
- Descendant · cites it directly · 3 of its ownK193555 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corp · 2020
- Descendant · 2 generations on · 1 of its ownK244034 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK252244 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corporation · 2025
- Descendant · 2 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 4 of 4 · See all- K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corp · 2020 · cites it directly3descendants
- K244034Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corporation · 2025 · 2 generations on1descendant
- K252244Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corporation · 2025 · 3 generations on0descendants
- K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl…Zhonghong Pulin Medical Products Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −4 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −3 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −2 | K161422 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2016 | — |
| −1 | K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for… | Koon Seng Sdn Bhd | 2018 | — |
| 0 (this device) | K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With… | Ever Global (Vietnam) Enterprise Corporation | 2019 | — |
| +1 | K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corp | 2020 | — |
| +2 | K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corporation | 2025 | — |
| +3 | K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corporation | 2025 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with…Summary page 5…hemotherapy Drugs (Blue, Black) Company name: Koon Seng Sdn. Bhd. 510(K) Number: K171171 4.0 Device Description: Disposable Powder Free Nitrile Examination Glove, White/Blue Color, Tested For Use With Chemothe… | 2018 |
| † | K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With… | 2020 | 3 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K193555 (Ever Global (Vietnam) Enterprise Corp, 2020) has gone furthest, with 3 descendants 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. 2019, 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 patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers 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 ( Min)…
Read the full statement (298 words)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers 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 ( Min)
1. Carmustine (BCNU). 3.3 mg/ml 6.2
2. Thiotepa, 10.0 mg/ml 38.8
3. Cyclophosphamide (Cytoxan). 20.0 mg/ml =240
4. Cisplatin, 1.0 mg/ml =240
5. Doxorubicin Hydrochloride, 2.0 mg/ml =240
6. Fluorouracil. 50.0 mg/ml =240
7. Dacarbazine (DTIC), 10.0 mg/ml =240
8. Etoposide (Toposar). 20.0 mg/ml > 240
9. Paclitaxel (Taxol). 6.0 mg/ml =240
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 6.2 minutes
Thiotepa, 10.0 mg/ml 38.8 minutes
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers 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 ( Min)
1. Carmustine (BCNU), 3.3 mg/ml 228
2. Thiotepa. 10.0 mg/ml 546
3. Cyclophosphamide (Cytoxan), 20.0 mg/ml =240
4. Cisplatin. 1.0 mg/ml =240
5. Doxorubicin Hydrochloride, 2.0 mg/ml =240
6. Fluorouracil, 50.0 mg/ml =240
7. Dacarbazine (DTIC). 10.0 mg/ml =240
8. Etoposide (Toposar), 20.0 mg/ml =240
9. Paclitaxel (Taxol), 6.0 mg/ml =240
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 8 minutes
Thiotepa, 10.0 mg/ml 54.6 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/K190403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190403: Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190403
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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