510(k) · Cleared
ClearedNitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (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 Nov 11, 2022 as substantially equivalent to K151997 (Hartalega NGC Sdn. Bhd., 2016) after a 109-day review. Its family tree reaches back 1 generation to 2016. 1 later device descends from it.
- Decided
- Nov 11, 2022
- Review
- 109 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K151997 (2016). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK151997 Nitrile Powder Free Examination Gloves Tested for Use with…Hartalega NGC Sdn. Bhd. · 2016
- This deviceK222225 Nitrile Powder Free Examination Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2022
- Descendant · cites it directly · 0 of its ownK243818 Nitrile Powder Free Examination Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243818Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…Hartalega NGC Sdn. Bhd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K151997 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy… | Hartalega NGC Sdn. Bhd. | 2016 | — |
| 0 (this device) | K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs… | Hartalega NGC Sdn. Bhd. | 2022 | — |
| +1 | K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs… | Hartalega NGC Sdn. Bhd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K151997 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet…Summary page 6…Code Nitrile Powder Free Examination Glove Tested for Use with K151997 LZA Chemot… | 2016 |
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 |
|---|---|---|---|
| K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and… | 2025 | 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. 2022, 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 Glove Tested for Use with Chemotherapy Drugs (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. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation…
Read the full statement (257 words)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (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.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in 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 (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
Bleomycin Sulfate, 15.0 mg/ml >240
Bortezomib, 1.0 mg/ml >240
Busulfan, 6.0 mg/ml >240
Carboplatin, 10.0 mg/ml >240
Chloroquine, 50.0 mg/ml >240
Cyclosporin A, 100.0 mg/ml >240
Cytarabine, 100.0 mg/ml >240
Daunorubicin, 5.0 mg/ml >240
Docetaxel, 10.0 mg/ml >240
Epirubicin, 2.0 mg/ml >240
Fludarabine, 25.0 mg/ml >240
Gemcitabine, 38.0 mg/ml >240
Idarubicin, 1.0 mg/ml >240
lfosfamide, 50.0 mg/ml >240
Irinotecan, 20.0 mg/ml >240
Mechlorethamine HCI, 1.0 mg/ml >240
Melphalan, 5.0 mg/ml >240
Mitoxantrone, 2.0 mg/ml >240
Oxaliplatin, 2.0 mg/ml >240
Paraplatin, 10.0 mg/ml >240
Retrovir, 10.0 mg/ml >240
Rituximab, 10.0 mg/ml >240
Topotecan, 1.0 mg/ml >240
Trisenox, 1.0 mg/ml >240
Caution: Testing showed an average breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa.
Warning: Do not use with Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222225 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222225: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222225
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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