510(k) · Cleared
ClearedPowder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kossan International Sdn Bhd3 · LZA Polymer Patient Examination Glove
Cleared on Mar 15, 2023 after a 131-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 15, 2023
- Review
- 131 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?
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate 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…
Read the full statement (341 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate 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
Bendamustine HCI (Treanda) (5 mg/ml): >240
Bleomycin Sulfate (15 mg/ml): >240
Busulfan (6 mg/ml): >240
Carboplatin (10 mg/ml): >240
Carfilzomib (2 mg/ml): >240
Carmustine (BCNU) (3.3 mg/ml): 26.2
Cetuximab (Erbitux) (2 mg/ml): >240
Cisplatin (1 mg/ml): >240
Cladribine (1 mg/ml): >240
Cyclosporin A (100 mg/ml): >240
Cyclophosphamide (Cytoxan) (20 mg/ml): >240
Cytarabine (100 mg/ml): >240
Cytovene (Ganciclovir) (10 mg/ml): >240
Dacarbazine (DTIC) (10 mg/ml): >240
Daunorubicin HCI (5 mg/ml): >240
Decitabine (5 mg/ml): >240
Docetaxel (Taxotere) (20 mg/ml): >240
Doxorubicin Hydrochloride (2 mg/ml): >240
Epirubicin HCI (Ellence) (2 mg/ml): >240
Etoposide (20 mg/ml): >240
Fludarabine (25 mg/ml): >240
Fluorouracil (50 mg/ml): >240
Gemcitabine (38 mg/ml): >240
Idarubicin HCI (1 mg/ml): >240
Ifosfamide (50 mg/ml): >240
Irinotecan (20 mg/ml): >240
Mechlorethamine HCI (1 mg/ml): >240
Melphalan (5 mg/ml): >240
Methotrexate (25 mg/ml): >240
Mitomycin C (0.5 mg/ml): >240
Mitoxantrone (2 mg/ml): >240
Oxaliplatin (5 mg/ml): >240
Paclitaxel (Taxol) (6 mg/ml): >240
Pemetrexed (25 mg/ml): >240
Raltitrexed (0.5 mg/ml): >240
Retrovir (Zidovudine) (10 mg/ml): >240
Rituximab (10 mg/ml): >240
Thiotepa (10 mg/ml): 59.1
Topotecan (1 mg/ml): >240
Trisenox (Arsenic Trioxide) (1 mg/ml): >240
Velcade (Bortezomib) (1 mg/ml): >240
Vidaza (Azacytidine) (25 mg/ml): >240
Vinblastine (1 mg/ml): >240
Vincristine Sulfate (1 mg/ml): >240
Vinorelbine (10 mg/ml): >240
Zoledronic Acid (1 mg/25ml): >240
Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 26.2 and 59.1 minutes respectively.
Warning: Do Not Use with Carmustine (BCNU)
Caution: Thiotepa has low permeation times of 59.1 minutes
Opioid and Concentration — Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection (100 mcg/2ml): >240
Simulated Gastric Acid Fluid — Minimum Breakthrough Detection Time in Minutes
Simulated Gastric Acid Fluid: >240
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K223375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223375: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223375
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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