510(k) · Cleared
ClearedDisposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Growth (Vietnam) Corporation Limited · LZA Polymer Patient Examination Glove
Cleared on Mar 27, 2024 as substantially equivalent to K190736 (Ever Growth (Vietnam) Co., Ltd., 2019) after a 92-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Mar 27, 2024
- Review
- 92 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K042805 (2004). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 6 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 5 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 4 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 3 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 2 generations backK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
- 1 generation backK190736 Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested…Ever Growth (Vietnam) Co., Ltd. · 2019
- This deviceK234097 Disposable Powder Free Nitrile Examination Glove, Natural Blue…Ever Growth (Vietnam) Corporation Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −6 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −5 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −4 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −3 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −2 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2018 | — |
| −1 | K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use… | Ever Growth (Vietnam) Co., Ltd. | 2019 | — |
| 0 (this device) | K234097 | Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested… | Ever Growth (Vietnam) Corporation Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With…Summary page 6…Use with Chemotherapy Drugs Company name: EVER GROWTH (VIETNAM) CORPORATION LIMITED 510(K) Number: K190736 Page 1 of 8 510(k) SUMM… | 2019 |
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 20 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K190736.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 non-powdered 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 respectively for use with chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. No. Test Chemotherapy Drug and…
Read the full statement (313 words)
A non-powdered 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 respectively for use with chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
No. Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Min.)*
1 Bleomycin Sulfate 15.0 mg/ml > 240
2 Busulfan 6.0 mg/ml > 240
3 Carboplatin 10.0 mg/ml > 240
4 Carmustine (BCNU) 3.3 mg/ml 59.4
5 Chloroquine 50.0 mg/ml > 240
6 Cisplatin 1 mg/ml > 240
7 Cyclophosphamide 20 mg/ml > 240
8 Cyclosporin A 100.0 mg/ml > 240
9 Cytarabine 100.0 mg/ml > 240
10 Dacarbazine (DTIC), 10.0 mg/ml > 240
11 Daunorubicin 5.0 mg/ml > 240
12 Docetaxel 10.0 mg/ml > 240
13 Doxorubicin Hydrochloride 2.0 mg/ml > 240
14 Epirubicin 2.0 mg/ml > 240
15 Etoposide (Toposar) 20.0 mg/ml > 240
16 Fludarabine 25.0 mg/ml > 240
17 Fluorouracil 50.0 mg/ml > 240
18 Gemcitabine 38.0 mg/ml > 240
19 Idaribicin 1.0 mg/ml > 240
20 Ifosfamide 50.0 mg/ml > 240
21 Irinotecan 20.0 mg/ml > 240
22 Mechlorethamine HCl 1.0 mg/ml > 240
23 Melphalan 5.0 mg/ml > 240
24 Methotrexate 25 mg/ml > 240
25 Mitomycin C 0.5 mg/ml > 240
26 Mitoxantrone 2.0 mg/ml > 240
27 Oxaliplatin 2.0 mg/ml > 240
28 Paclitaxel (Taxol), 6.0 mg/ml > 240
29 Paraplatin 10 mg/ml > 240
30 Retrovir 10 mg/ml > 240
31 Rituximab 10 mg/ml > 240
32 Thiotepa, 10.0 mg/ml 118.5
33 Topotecan HCl 1.0 mg/ml > 240
34 Trisonex 1.0 mg/ml > 240
35 Velcade (Bortezomib) 1.0 mg/ml > 240
36 Vincristine 1.0 mg/ml > 240
Fentanyl Citrate Test
Fentanyl Citrate Injection 100 mcg/2ml >240
Thiotepa and Carmustine have low permeation times
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/K234097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234097: Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234097
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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