510(k) · Cleared
ClearedBlack Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, 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 Jul 24, 2023 after a 221-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 24, 2023
- Review
- 221 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?
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, 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 chloroquine, cyclosporin A, retrovir, gastric acid and fentanyl citrate…
Read the full statement (493 words)
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, 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 chloroquine, cyclosporin A, retrovir, gastric acid and fentanyl citrate in accordance with ASTM D6978-05(2019).
Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows:
Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes
Bleomycin Sulfate | 15.0 mg/ml | > 240 mins
Busulfan | 6.0 mg/ml | > 240 mins
Carboplatin | 10.0 mg/ml | > 240 mins
Carmustine (BCNU) | 3.3 mg/ml | 13.2 mins
Cisplatin | 1.0 mg/ml | > 240 mins
Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 mins
Cytarabine (Cytosine) | 100.0 mg/ml | > 240 mins
Dacarbazine | 10.0 mg/ml | > 240 mins
Daunorubicin HCI | 5.0 mg/ml | > 240 mins
Docetaxel | 10.0 mg/ml | > 240 mins
Doxorubicin HCI | 2.0 mg/ml | > 240 mins
Epirubicin HCI (Ellence) | 2.0 mg/ml | > 240 mins
Etoposide (Toposar) | 20.0 mg/ml | > 240 mins
Fludarabine | 25.0 mg/ml | > 240 mins
Fluorouracil | 50.0 mg/ml | > 240 mins
Gemcitabine (Gemzar) | 38.0 mg/ml | > 240 mins
Idarubicin HCI | 1.0 mg/ml | > 240 mins
Ifosfamide | 50.0 mg/ml | > 240 mins
Irinotecan | 20.0 mg/ml | > 240 mins
Mechlorethamine HCl | 1.0 mg/ml | > 240 mins
Melphalan | 5.0 mg/ml | > 240 mins
Methotrexate | 25.0 mg/ml | > 240 mins
Mitomycin C | 0.5 mg/ml | > 240 mins
Mitoxantrone HCl | 2.0 mg/ml | > 240 mins
Oxaliplatin | 5.0 mg/ml | > 240 mins
Paclitaxel | 6.0 mg/ml | > 240 mins
Paraplatin | 10.0 mg/ml | > 240 mins
Rituximab | 10.0 mg/ml | > 240 mins
Thiotepa | 10.0 mg/ml | 34.7 mins
Topotecan HCI | 1.0 mg/ml | > 240 mins
Trisenox (Arsenic Trioxide) | 1.0 mg/ml | > 240 mins
Velcade (Bortezomib) | 1.0 mg/ml | > 240 mins
Vincristine Sulfate | 1.0 mg/ml | > 240 mins
Tested non-chemotherapy drugs and average breakthrough detection time (minutes) are as follows:
Non-Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes
Chloroquine | 50.0 mg/ml | > 240 mins
Cyclosporin A | 100.0 mg/ml | > 240 mins
Retrovir | 10.0 mg/ml | > 240 mins
Fentanyl Permeation - Under the testing conditions of ASTM D6978-05(2019), Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Gastric Acid Permeation - Under the testing conditions of ASTM D6978-05(2019), was found to have no breakthrough detected up to 240 minutes.
CAUTION: Testing showed an average breakthrough time of 13.2 minutes with Carmustine and 34.7 minutes with Thiotepa.
WARNING: Do not use with Carmustine and Thiotepa.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223752 · printed Nov 3, 2026
Cite this page
510(k) Report. “K223752: Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K223752
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