510(k) · Cleared
ClearedBiodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hartalega NGC Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on May 17, 2023 as substantially equivalent to K200581 (Hartalega NGC Sdn. Bhd., 2020) after a 184-day review. Its family tree reaches back 1 generation to 2020. 1 later device descends from it.
- Decided
- May 17, 2023
- Review
- 184 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K200581 (2020). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK200581 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use…Hartalega NGC Sdn. Bhd. · 2020
- This deviceK223437 Biodegradable Nitrile Powder Free Examination Glove Tested for Use…Hartalega NGC Sdn. Bhd. · 2023
- Descendant · cites it directly · 0 of its ownK232070 Biodegradable Nitrile Examination Gloves Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232070Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and…Better Care Plastic Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with… | Hartalega NGC Sdn. Bhd. | 2020 | — |
| 0 (this device) | K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with… | Hartalega NGC Sdn. Bhd. | 2023 | — |
| +1 | K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Summary page 6…Tradename Product Code Biodegradable Nitrile Powder Free Examination Glove Tested for Use K200581 LZA. LZC, QDO… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and… | 2023 | 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?
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?
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019)…
Read the full statement (247 words)
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes
5-Azacytidine (25.0 mg/ml) > 240
Carboplatin (10.0 mg/ml) > 240
Carmustine (3.3 mg/ml) 12.1
Cisplatin (1.0 mg/ml) > 240
Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240
Dacarbazine (10.0 mg/ml) > 240
Doxetacel (10.0 mg/ml) > 240
Doxorubicin HCI (2.0 mg/ml) > 240
Epirubicin (2.0 mg/ml) > 240
Etoposide (20.0 mg/ml) > 240
Fluorouracil (50.0 mg/ml) > 240
Gemcitabine (38.0 mg/ml) > 240
Ifosfamide (50.0 mg/ml) > 240
Irinotecan (20.0 mg/ml) > 240
Methotrexate (25.0 mg/ml) > 240
Mitomycin C (0.5 mg/ml) > 240
Mitoxantrone (2.0 mg/ml) > 240
Oxalipatin (5.0 mg/ml) > 240
Paclitaxel (6.0 mg/ml) > 240
Thiotepa (10.0 mg/ml) 37.8
Vincristine Sulfate (1.0 mg/ml) > 240
Oncovin (1.0 mg/ml) > 240
Vinorelbine (10.0mg/ml) > 240
Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection (100mcg/2ml) >240
Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 12.1 minutes and 37.8 minutes.
Warning: Do not use with Carmustine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223437 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223437: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223437
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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