510(k) · Cleared
ClearedNitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue
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 Jul 20, 2026 as substantially equivalent to K162923 (Hartalega NGC Sdn. Bhd., 2017) after a 201-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Jul 20, 2026
- Review
- 201 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K162923 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backK162923 Nitrile Powder Free Examination Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2017
- This deviceK254285 Nitrile Powder Free Examination Gloves Tested for Use with…Hartalega NGC Sdn. Bhd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K162923 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs -… | Hartalega NGC Sdn. Bhd. | 2017 | — |
| 0 (this device) | K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs… | Hartalega NGC Sdn. Bhd. | 2026 | — |
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 |
|---|---|---|---|
| * | K162923 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua…Summary page 7…: LZA, LZC, OPJ Regulation Number : 21 CFR 880.6250 PREDICATE DEVICE INFORMATION: 510(k) Number : K162923 Manufacturer : Hartalega NGC Sdn. Bhd. Trade Name (Proprietary Name) : Nitrile Powder… | 2017 |
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?
- Its one ancestor has no 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. 2026, 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?
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue 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. The list of Chemotherapy Drugs tested (with breakthrough time) are: Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time Minutes…
Read the full statement (423 words)
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue 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.
The list of Chemotherapy Drugs tested (with breakthrough time) are:
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time Minutes
Carmustine (3.3 mg/ml) 10.3
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(Toposar)(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) 28.8
Vincristine Sulfate (1.0 mg/ml) >240
Caution: Testing showed a minimum breakthrough time of 10.3 minutes with Carmustine and 28.8 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa.
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue 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.
The list of Chemotherapy Drugs tested (with breakthrough time) are:
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time Minutes
Carmustine (3.3 mg/ml) 10.2
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(Toposar)(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) 30.2
Vincristine Sulfate (1.0 mg/ml) >240
Caution: Testing showed a minimum breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa.
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue 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.
The list of Chemotherapy Drugs tested (with breakthrough time) are:
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time Minutes
Carmustine (3.3 mg/ml) 7.3
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(Toposar)(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) 20.6
Vincristine Sulfate (1.0 mg/ml) >240
Caution: Testing showed a minimum breakthrough time of 7.3 minutes with Carmustine and 20.6 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254285: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254285
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026