510(k) · Cleared
ClearedDisposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Growth (Vietnam) Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Dec 23, 2019 as substantially equivalent to K182176 (Pt. Medisafe Technologies, 2019) after a 265-day review. Its family tree reaches back 1 generation to 2019. 12 later devices descend from it.
- Decided
- Dec 23, 2019
- Review
- 265 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K182176 (2019). 12 later devices descend from it, 12 citing it directly.
- Root · 1 generation backK182176 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested…Pt. Medisafe Technologies · 2019
- This deviceK190860 Disposable Powder Free Nitrile Examination Glove, Tested For Use…Ever Growth (Vietnam) Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK230847 Chemotherapy Gloves3A Glove Sdn. Bhd. · 2023
- Descendant · cites it directly · 0 of its ownK214056 Disposable Nitrile Inspection Gloves (Tested for Use with…Mezorrison Medical Technology (Dongying) Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK221271 Disposable Nitrile Powder-Free Examination Gloves (Tested for Use…Shandong Maida Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK220488 Disposable Nitrile Powder-Free Examination Gloves (Tested for Use…Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK220382 Disposable Nitrile Examination Gloves (Tested for Use with…Jiangsu Bytech Medical Supplies Co., Ltd. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K230847Chemotherapy Gloves3A Glove Sdn. Bhd. · 2023 · cites it directly0descendants
- K214056Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)Mezorrison Medical Technology (Dongying) Co., Ltd. · 2022 · cites it directly0descendants
- K221271Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)Shandong Maida Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
- K220488Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · 2022 · cites it directly0descendants
- K220382Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) -…Jiangsu Bytech Medical Supplies Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use… | Pt. Medisafe Technologies | 2019 | — |
| 0 (this device) | K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With… | Ever Growth (Vietnam) Co., Ltd. | 2019 | — |
| +1 | K230847 | Chemotherapy Gloves | 3A Glove Sdn. Bhd. | 2023 | — |
| +1 | K214056 | Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) | Mezorrison Medical Technology (Dongying) Co., Ltd. | 2022 | — |
| +1 | K221271 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with… | Shandong Maida Medical Technology Co., Ltd. | 2022 | — |
| +1 | K220488 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with… | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. | 2022 | — |
| +1 | K220382 | Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)… | Jiangsu Bytech Medical Supplies Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with… Our reading of the summary gave K182156, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with…”. | 2019 |
What descends from it? (12)
See all 1212 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230847 | Chemotherapy Gloves | 2023 | 0 |
| K214056 | Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) | 2022 | 0 |
| K221271 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) | 2022 | 0 |
| K220488 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) | 2022 | 0 |
| K220382 | Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) -… | 2022 | 0 |
| K213662 | Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) | 2022 | 0 |
| K213051 | Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) | 2021 | 0 |
| K213048 | Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) | 2021 | 0 |
| K212919 | Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | 2021 | 0 |
| K212789 | Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | 2021 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K230847 (3A Glove Sdn. Bhd., 2023) has gone furthest, with 0 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 | Concentration(mg/ml) | Minimum Breakthrough Detection Time…
Read the full statement (308 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 | Concentration(mg/ml) | Minimum Breakthrough Detection Time ( Min)
1 Carmustine (BCNU), 3.3 mg/ml 11.8
2 Thiotepa, 10.0 mg/ml 16.9
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 11.8 minutes
Thiotepa 10.0 mg/ml 16.9 minutes
Warning: Please do not use with Carmustine (BCNU) and Thiotepa
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 | Concentration(mg/ml) | Minimum Breakthrough Detection Time ( Min)
1 Carmustine (BCNU), 3.3 mg/ml 31.6
2 Thiotepa, 10.0 mg/ml 72.5
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 31.6 minutes
Thiotepa 10.0 mg/ml 72.5 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190860 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190860: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190860
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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