510(k) · Cleared
ClearedPowder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gx Corporation Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Jun 20, 2019 after a 199-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 20, 2019
- Review
- 199 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. 2019, 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?
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below. Chemotherapy Drug permeation and concentration ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves. Chemotherapy Drugs: Breakthrough Detection Time in Minutes 1. Carmustine…
Read the full statement (353 words)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Chemotherapy Drug permeation and concentration ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves.
Chemotherapy Drugs: Breakthrough Detection Time in Minutes
1. Carmustine ( BCNU)3.3 mg/ml(3,300 ppm) 54.8 min
2. Cisplatin 1.0 mg/ml ( I,000ppm) >240 min
3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) >240 min
4. Dacarbazine (DTIC) I 0.0 mg/ml( l 0,000ppm) >240 min
5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) >240 min
6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) >240 min
7. Fluorouracil 50.0 mg/ml (50,000ppm) >240 min
8. Ifosfamide 50.0 mg/ml (50,000ppm) >240 min
9. Methotrexate 25 mg/ml (25,000ppm) >240 min
10.Mitomycin C 0.5 mg/ml (500ppm) >240 min
11. Mitoxantrone 2.0 mg/ml (2,000ppm) >240 min
12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) >240 min
13. Thio-Tepa 10.0 mg/ml ( l0,O00ppm) 46.9 min
14.Vincristine Sulfate 1.0 mg/ml ( l,000ppm) >240 min
15. Amethopterin (Methotrexate) 25 mg/ml, (25,000 ppm) >240 min
16. Bleomycin 15 mg/ml (15,000 ppm) >240 min
17. Busulfan 6 mg/ml (6,000 ppm) >240 min
18. Carboplatin IO mg/ml ( I0,000 ppm) >240 min
19. Cytarabine JOO mg/ml (100.000 ppm) >240 min
20. Daunorubicin 5 mg/ml (5,000 ppm) >240 min
21. Doxetacel 10.0 mg/ml (10,000 ppm) >240 min
22. Ellence 2 mg/ml (2,000 ppm) >240 min
23. Fludarabine 25 mg/ml (25,000 ppm) >240 min
24. Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) >240 min
25. ldarubicin I mg/ml (1,000 ppm) >240 min
26. lrinotecan 20.0 mg/ml (20,000 ppm) >240 min
27. Mechloretamine HCL 1.0 mg/ml (1,000 ppm) >240 min
28. Melphalan 5 mg/ml (5,000 ppm) >240 min
29. Oxaliplatin 2.0 mg.ml (2,000 ppm) >240 min
30. Rituximab IO mg/ml ( I0,000 ppm) >240 min
31. Trisonex 0.1 mg/ml ( I00 ppm) >240 min
32. Vinorelbin IO mg/ml ( I 0,000 ppm) >240 min
plus Other Drugs
1. Fentanyl Citrate Injection I 00 mcg/2ml >240min
Please Note that the following Drugs have extremely low permeation times : Carmustine : 54,8 minutes and Thio-Tepa: 46.9 minutes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K183354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183354: Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183354
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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