510(k) · Cleared
ClearedNitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Top Glove Medical (Thailand) Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Feb 10, 2023 after a 207-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 10, 2023
- Review
- 207 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. 2023, 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?
An examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. No Test Chemotherapy Drug — Concentration (mg/ml) — Minimum breakthrough Detection Time (min) 1 Blenoxane — 15 — >240 2 Busulfan…
Read the full statement (630 words)
An examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
No Test Chemotherapy Drug — Concentration (mg/ml) — Minimum breakthrough Detection Time (min)
1 Blenoxane — 15 — >240
2 Busulfan — 6 — >240
3 Carboplatin — 10 — >240
4 Carmustine (BCNU) — 3.3 — 16.7
5 Cisplatin — 1 — >240
6 Cyclophosphamide — 20 — >240
7 Cytarabine — 100 — >240
8 Dacarbazine — 10 — >240
9 Daunorubicin HCl — 5 — >240
10 Docetaxel — 10 — >240
11 Doxorubicin HCl — 2.0 — >240
12 Etoposide — 20 — >240
13 Ellence — 2 — >240
14 Fludarabine — 25 — >240
15 Fluorouracil — 50 — >240
16 Ganciclovir — 10 — >240
17 Gemcitabine — 38 — >240
18 Idarubicin HCl — 1 — >240
19 lfosfamide — 50 — >240
20 Irinotecan — 20 — >240
21 Mechlorethamine HCl — 1 — >240
22 Melphalan — 5 — >240
23 Methotrexate — 25 — >240
24 Mitomycin C — 0.5 — >240
25 Mitoxantrone HCl — 2 — >240
26 Oxaliplatin — 5 — >240
27 Paclitaxel — 6.0 — >240
28 Rituximab — 10 — >240
29 Thiotepa — 10.0 — 35.0
30 Trisenox — 1 — >240
31 Vincristine Sulfate — 1 — >240
32 Vinorelbine — 10 — >240
Test Drug — Concentration — Minimum breakthrough Detection Time (min)
Fentanyl Citrate — 100 mcg/2ml — >240
Please note that Carmustine and Thiotepa have extremely low permeation times of 16.7 minutes and 35 minutes respectively.
WARNING:
Do not use Carmustine
CAUTION:
Testing showed an average breakthrough time of35 minutes with Thiotepa.
An examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
No Test Chemotherapy Drug — Concentration (mg/ml) — Minimum breakthrough Detection Time (min)
1 Blenoxane — 15 — >240
2 Busulfan — 6 — >240
3 Carboplatin — 10 — >240
4 Carmustine (BCNU) — 3.3 — 14.2
5 Cisplatin — 1 — >240
6 Cyclophosphamide — 20 — >240
7 Cytarabine — 100 — >240
8 Dacarbazine — 10 — >240
9 Daunorubicin HCl — 5 — >240
10 Docetaxel — 10 — >240
11 Doxorubicin HCl — 2.0 — >240
12 Etoposide — 20.0 — >240
13 Ellence — 2 — >240
14 Fludarabine — 2 — >240
15 Fluorouracil — 50 — >240
16 Ganciclovir — 10 — >240
17 Gemcitabine — 38 — >240
18 Idarubicin HCl — 1 — >240
19 lfosfamide — 50 — >240
20 Irinotecan — 20 — >240
21 Mechlorethamine HCl — 1 — >240
22 Melphalan — 5 — >240
23 Methotrexate — 25 — >240
24 Mitomycin C — 0.5 — >240
25 Mitoxantrone HCl — 2 — >240
26 Oxaliplatin — 5 — >240
27 Paclitaxel — 6.0 — >240
28 Rituximab — 10 — >240
29 Thiotepa — 10.0 — 24.1
30 Trisenox — 1 — >240
31 Vincristine Sulfate — 1 — >240
32 Vinorelbine — 10 — >240
Test Drug — Concentration — Minimum breakthrough Detection Time (min)
Fentanyl Citrate — 100 mcg/2ml — >240
Please note that Carmustine and Thiotepa have extremely low permeation times of 14.2 minutes and 24.1 minutes respectively.
WARNING:
Do not use Carmustine and Thiotepa
CAUTION:
Testing showed an average breakthrough time of24.1 minutes with Thiotepa.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K222129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222129: Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222129
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026