510(k) · Cleared
ClearedNitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark Blue; Nitrile Powder Free Examination Glove 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 Feb 6, 2017 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 6, 2017
- Review
- 111 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK162923 Nitrile Powder Free Examination Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2017
- Descendant · cites it directly · 0 of its ownK254285 Nitrile Powder Free Examination Gloves Tested for Use with…Hartalega NGC Sdn. Bhd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua…Hartalega NGC Sdn. Bhd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K162923 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs -… | Hartalega NGC Sdn. Bhd. | 2017 | — |
| +1 | K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs… | Hartalega NGC Sdn. Bhd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua… | 2026 | 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?
- Of its descendants, K254285 (Hartalega NGC Sdn. Bhd., 2026) 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. 2017, 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 Nitrile Powder Free Examination Glove 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 times) are; Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes) Carmustine…
Read the full statement (507 words)
The Nitrile Powder Free Examination Glove 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 times) are;
Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes)
Carmustine (BCNU) 3.3 10.3
Cisplatin 1.0 >240
Cyclophosphamide (Cytoxan) 20.0 >240
Dacarbazine 10.0 >240
Doxorubixin Hydrochloride 2.0 >240
Etoposide (Toposar) 20.0 >240
Fluorouracil 50.0 >240
Methotrexate 25.0 >240)
Mitomycin C 0.5 >240
Paclitaxel (Taxol) 6.0 >240
Thiotepa 10.0 28.8
Vincristine Sulfate 1.0 >240
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 10.3 and 28.8 minutes respectively.
The Nitrile Powder Free Examination Glove 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 times) are;
Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes)
Carmustine (BCNU) 3.3 10.2
Cisplatin 1.0 >240)
Cyclophosphamide (Cytoxan) 20.0 >240
Dacarbazine 10.0 >240
Doxorubixin Hydrochloride 2.0 >240
Etoposide (Toposar) 20.0 >240
Fluorouracil 50.0 >240
Methotrexate 25.0 >240
Mitomycin C 0.5 >240
Paclitaxel (Taxol) 6.0 >240
Thiotepa 10.0 30.2
Vincristine Sulfate 1.0 >240
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 10.2 and 30.2 minutes respectively.
The Nitrile Powder Free Examination Glove 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 times) are;
Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes)
Carmustine (BCNU) 3.3 7.3
Cisplatin 1.0 >240
Cyclophosphamide (Cytoxan) 20.0 >240
Dacarbazine 10.0 >240
Doxorubixin Hydrochloride 2.0 >240
Etoposide (Toposar) 20.0 >240
Fluorouracil 50.0 >240
Methotrexate 25.0 >240
Mitomycin C 0.5 >240
Paclitaxel (Taxol) 6.0 >240
Thiotepa 10.0 20.6
Vincristine Sulfate 1.0 >240
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 7.3 and 20.6 minutes respectively.
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark 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 times) are;
Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes)
Carmustine (BCNU) 3.3 0.2
Cisplatin 1.0 >240
Cyclophosphamide (Cytoxan) 20.0 >240
Dacarbazine 10.0 >240
Doxorubixin Hydrochloride 2.0 >240
Etoposide (Toposar) 20.0 >240
Fluorouracil 50.0 >240
Methotrexate 25.0 >240
Mitomycin 0.5 >240
Paclitaxel 6.0 >240
Thiotepa 10.0 10.3
Vincristine Sulfate 1.0 >240
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 0.2 and 10.3 minutes respectively.
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/K162923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162923: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark Blue; Nitrile Powder Free Examination Glove 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/K162923
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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