510(k) · Cleared
ClearedSterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
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 Nov 2, 2018 after a 221-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 2, 2018
- Review
- 221 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)- Extended Cuff 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. The list of Chemotherapy Drugs tested (with breakthrough times) is as below: Carmustine (3.3 mg/ml) Cisplatin (1.0 mg/ml)…
Read the full statement (304 words)
The Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)- Extended Cuff 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.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below:
Carmustine (3.3 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20 mg/ml)
Dacarbazine (10.0 mg/ml)
Doxorubicin Hydrochloride (2.0mg/ml)
Etoposide (20.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Paclitaxel (6.0 mg/ml)
Thiotepa (10.0 mg/ml)
Vincristine Sulfate (1.0 mg/ml)
20.3 minutes
> 240 minutes
> 240 minutes
> 240 minutes
> 240 minutes
> 240 minutes
> 240 minutes
> 240 minutes
> 240 minutes
> 240 minutes
100.6 minutes
> 240 minutes
Please note that Carmustine and Thiotepa have extremely low permeation times of 20.3 minutes and 100.6 minutes.
The Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue (ABLU) 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.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below:
Carmustine (3.3 mg/ml) 43.8 minutes
Cisplatin (1.0 mg/ml) > 240 minutes
Cyclophosphamide (20 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) > 240 minutes
Doxorubicin Hydrochloride (2.0mg/ml) > 240 minutes
Etoposide (20.0 mg/ml) > 240 minutes
Fluorouracil (50.0 mg/ml) > 240 minutes
Methotrexate (25 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxel (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 97.8 minutes
Vincristine Sulfate (1.0 mg/ml) > 240 minutes
Please note that Carmustine and Thiotepa have extremely low permeation times of 43.8 minutes and 97.8 minutes.
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/K180786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180786: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180786
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026