510(k) · Cleared
ClearedSterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hartalega Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Aug 5, 2020 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Aug 5, 2020
- Review
- 58 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK201531 Sterile Nitrile Powder Free Examination Glove Tested for Use with…Hartalega Sdn Bhd · 2020
- Descendant · cites it directly · 0 of its ownK251319 Sterile Nitrile Powder Free Examination Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2025
- Descendant · cites it directly · 0 of its ownK220249 Sterile Nitrile Powder Free Examination Gloves Tested For Use With…Grand Work Plastic Products Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See all- K251319Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…Hartalega NGC Sdn. Bhd. · 2025 · cites it directly0descendants
- K220249Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs…Grand Work Plastic Products Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy… | Hartalega Sdn Bhd | 2020 | — |
| +1 | K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy… | Hartalega NGC Sdn. Bhd. | 2025 | — |
| +1 | K220249 | Sterile Nitrile Powder Free Examination Gloves Tested For Use With… | Grand Work Plastic Products Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K251319 (Hartalega NGC Sdn. Bhd., 2025) 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. 2020, 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?
The Sterile Nltrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a 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. The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved…
Read the full statement (197 words)
The Sterile Nltrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a 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.
The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate 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
Carmustine (3.3 mg/ml) 26.3
Cisplatin (1.0 mg/ml) >240
Cyclophosphamide (20.0 mg/ml) >240
Dacarbazine (10.0 mg/ml) >240
Doxorubicin Hydrochloride (2.0 mg/ml) >240
Etoposide (20.0 mg/ml) >240
Fluorouracil (50.0 mg/ml) >240
Methotrexate (25.0 mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Paclitaxel (6.0 mg/ml) >240
Thiotepa (10.0 mg/ml) 97.1
Vincristine Sulfate (1.0 mg/ml) >240
Please note that Carmustine and Thiotepa have extremely low permeation times of 26.3 minutes and 97.1 minutes respectively. Warning statements has been included.
WARNING: DO NOT USE WITH CARMUSTINE
WARNING: DO NOT USE WITH THIOTEPA
Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection (100 mcg/2ml) >240
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201531 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201531: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201531
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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