510(k) · Cleared
ClearedBlue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Central Medicare Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Oct 2, 2023 after a 203-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 2, 2023
- Review
- 203 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?
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner . In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05. Tested chemotherapy drugs and…
Read the full statement (430 words)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner . In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05.
Tested chemotherapy drugs and breakthrough detection time (minutes) are as follows:
Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
Arsenic Trioxide 1.0mg/ml > 240minutes
Azacitidine (Vidaza) 25.0mg/ml > 240minutes
Bendamustine HCl 5.0mg/ml > 240minutes
Bleomycin Sulfate 15.0mg/ml > 240minutes
Busulfan 6.0mg/ml > 240minutes
Carboplatin 10.0mg/ml > 240minutes
Carmustine (BCNU) 3.3mg/ml 55.1minutes
Carfilzomib 2.0mg/ml > 240minutes
Cetuximab 2.0mg/ml > 240minutes
Chloroquine 50.0mg/ml > 240minutes
Cisplatin 1.0mg/ml > 240minutes
Cladribine 1.0mg/ml > 240minutes
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240minutes
Cyclosporin A 100.0mg/ml > 240minutes
Cytarabine 100.0mg/ml > 240minutes
Cytovene (Ganciclovir) 10.0mg/ml > 240minutes
Dacarbazine 10.0mg/ml > 240minutes
Daunorubicin 5.0mg/ml > 240minutes
Decitibine 5.0mg/ml > 240minutes
Docetaxel 10.0mg/ml > 240minutes
Doxorubicin Hydrochloride 2.0mg/ml > 240minutes
Epirubicin (Ellence) 2.0mg/ml > 240minutes
Etoposide (Toposar) 20.0mg/ml > 240minutes
Fludarabine 25.0mg/ml > 240minutes
Fluorouracil 50.0mg/ml > 240minutes
Fulvestrant 50.0mg/ml > 240minutes
Gemcitabine (Gemzar) 38.0mg/ml > 240minutes
Idarubicin 1.0mg/ml > 240minutes
lfosfamide 50.0mg/ml > 240minutes
Irinotecan 20.0mg/ml > 240minutes
Mechlorethamine HCl 1.0mg/ml > 240minutes
Melphalan 5.0mg/ml > 240minutes
Mesna 50.0mg/ml > 240minutes
Methotrexate 25.0mg/ml > 240minutes
Mitomycin C 0.5mg/ml > 240minutes
Mitoxantrone 2.0mg/ml > 240minutes
Oxaliplatin 2.0 mg/ml > 240 minutes
Paclitaxel 6.0 mg/ml > 240 minutes
Paraplatin 10.0 mg/ml > 240 minutes
Pemetrexed 25.0 mg/ml > 240 minutes
Pertuzumab 30.0 mg/ml > 240 minutes
Propofol 10.0 mg/ml > 240 minutes
Raltitrexed 0.5 mg/ml > 240 minutes
Retrovir 10.0 mg/ml > 240 minutes
Rituximab 10.0 mg/ml > 240 minutes
Temsirolimus 25.0 mg/ml > 240 minutes
Thiotepa 10.0 mg/ml 98.7 minutes
Topotecan HCl 1.0 mg/ml > 240 minutes
Trastuzumab 21.0 mg/ml > 240 minutes
Triclosan 2.0 mg/ml > 240 minutes
Trisenox (Arsenic Trioxide) 1.0 mg/ml > 240 minutes
Velcade (Bortezomib) 1.0 mg/ml > 240 minutes
Vinblastine 1.0 mg/ml > 240 minutes
Vincristine Sulfate 1.0 mg/ml > 240 minutes
Vinorelbine 10.0 mg/ml > 240 minutes
Zoledronic Acid 0.8 mg/ml > 240 minutes
Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Under the testing conditions of ASTM D6978-05, Gastric Acid was found to have no breakthrough detected up to 240 minutes.
CAUTION: Testing showed breakthrough time of 55.1 minutes with Carmustine and 98.7 minutes with Thiotepa.
WARNING: Do not use with Carmustine and Thiotepa.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K230681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230681: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230681
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026