510(k) · Cleared
ClearedNitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy Drugs
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 Sep 4, 2009 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Sep 4, 2009
- Review
- 87 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK091652 Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with…Hartalega Sdn Bhd · 2009
- Descendant · cites it directly · 0 of its ownK133949 Powder Free Nitrile Patient Examination Glove,Blue and Orange…Top Calibre Sdn Bhd · 2014
- Descendant · cites it directly · 0 of its ownK121506 Utb Blue Powder Free NitrileNorthstar Healthcare Holdings · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091652 | Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy… | Hartalega Sdn Bhd | 2009 | — |
| +1 | K133949 | Powder Free Nitrile Patient Examination Glove,Blue and Orange… | Top Calibre Sdn Bhd | 2014 | — |
| +1 | K121506 | Utb Blue Powder Free Nitrile | Northstar Healthcare Holdings | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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, K133949 (Top Calibre Sdn Bhd, 2014) 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. 2009, 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 examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.The list of chemotheraphy drugs tested (with breakthrough times) are as below: Chemotheraphy Drugs — Breakthrough Time (Minutes) 1. Carmustine — 6.60 2. Cisplatin — > 240 3. Cyclophosphamide (Cytoxan) — > 240 4. Dacarbazine — > 240…
Read the full statement (364 words)
The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.The list of chemotheraphy drugs tested (with breakthrough times) are as below:
Chemotheraphy Drugs — Breakthrough Time (Minutes)
1. Carmustine — 6.60
2. Cisplatin — > 240
3. Cyclophosphamide (Cytoxan) — > 240
4. Dacarbazine — > 240
5. Doxorubicin Hydrochloride — > 240
6. Etoposide — > 240
7. Fluorouracil — > 240
8. Methotrexate — > 240
9. Mitomycin — > 240
10. Paclitaxel — > 240
11. Thiotepa — 14.83
12. Vincristine Sulfate — > 240
"WARNING: Do not use with Carmustine and Thiotepa."
The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The list of chemotheraphy drugs tested (with breakthrough times) are as below:
Chemotheraphy Drugs — Breakthrough Time (Minutes)
1. Carmustine — 35.80
2. Cisplatin — > 240
3. Cyclophosphamide (Cytoxan) — > 240
4. Dacarbazine — > 240
5. Doxorubicin Hydrochloride — > 240
6. Etoposide — > 240
7. Fluorouracil — > 240
8. Methotrexate — > 240
9. Mitomycin — > 240
10. Paclitaxel — > 240
11. Thiotepa — 85.48
12. Vincristine Sulfate — > 240
"CAUTION: Testing showed an average breakthrough time of 35.80 minutes with Carmustine."
The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The list of chemotheraphy drugs tested (with breakthrough times) are as below:
Chemotheraphy Drugs — Breakthrough Time (Minutes)
1. Carmustine — 2.38
2. Cisplatin — > 240
3. Cyclophosphamide (Cytoxan) — > 240
4. Dacarbazine — > 240
5. Doxorubicin Hydrochloride — > 240
6. Etoposide — > 240
7. Fluorouracil — > 240
8. Methotrexate — > 240
9. Mitomycin — > 240
10. Paclitaxel — > 240
11. Thiotepa — 63.81
12. Vincristine Sulfate — > 240
"WARNING: Do not use with Carmustine."
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091652: Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091652
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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