510(k) · Cleared
ClearedBlue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.
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 Dec 22, 2021 after a 261-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 22, 2021
- Review
- 261 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. 2021, 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 Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of…
Read the full statement (516 words)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows:
Arsenic Trioxide 1.0 mg/ml >240 mins
Azacitidine (Vidaza) 25.0 mg/ml > 240 mins
Bendamustine HCI 5.0 mg/ml > 240 mins
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 12.7 mins
Carfilzomib 2.0 mg/ml > 240 mins
Cetuximab 2.0 mg/ml > 240 mins
Chloroquine 50.0 mg/ml > 240 mins
Cisplatin 1.0 mg/ml > 240 mins
Cladribine 1.0 mg/ml > 240 mins
Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 mins
Cyclosporin A 100.0 mg/ml > 240 mins
Cytarabine 100.0 mg/ml > 240 mins
Cytovene (Ganciclovir) 10.0 mg/ml > 240 mins
Dacarbazine 10.0 mg/ml > 240 mins
Daunorubicin 5.0 mg/ml > 240 mins
Decitibine 5.0 mg/ml > 240 mins
Docetaxel 10.0 mg/ml > 240 mins
Doxorubicin Hydrochloride 2.0 mg/ml > 240 mins
Epirubicin (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
Fulvestrant 50.0 mg/ml > 240 mins
Gemcitabine (Gemzar) 38.0 mg/ml > 240 mins
Idarubicin 1.0 mg/ml > 240 mins
Ifosfamide 50.0 mg/ml > 240 mins
Irinotecan 20.0 mg/ml > 240 mins
Mechlorethamine HCI 1.0 mg/ml > 240 mins
Melphalan 5.0 mg/ml > 240 mins
Mesna 50.0 mg/ml >240 mins
Methotrexate 25.0 mg/ml > 240 mins
Mitomycin C 0.5 mg/ml > 240 mins
Mitoxantrone 2.0 mg/ml > 240 mins
Oxaliplatin 2.0 mg/ml > 240 mins
Paclitaxel 6.0 mg/ml > 240 mins
Paraplatin 10.0 mg/ml > 240 mins
Pemetrexed 25.0 mg/ml > 240 mins
Pertuzumab 30.0 mg/ml >240 mins
Propofol 10.0 mg/ml > 240 mins
Raltitrexed 0.5 mg/ml > 240 mins
Retrovir 10.0 mg/ml > 240 mins
Rituximab 10.0 mg/ml > 240 mins
Temsirolimus 25.0 mg/ml >240 mins
Thiotepa 10 mg/ml 35.8 mins
Topotecan HCI 1.0 mg/ml > 240 mins
Trastuzumab 21.0 mg/ml >240 mins
Triclosan 2.0 mg/ml > 240 mins
Trisenox (Arsenic Trioxide) 1.0 mg/ml > 240 mins
Velcade (Bortezomib) 1.0 mg/ml > 240 mins
Vinblastine 1.0 mg/ml > 240 mins
Vincristine Sulfate 1.0 mg/ml > 240 mins
Vinorelbine 10.0 mg/ml > 240 mins
Zoledronic Acid 0.8 mg/ml > 240 mins
CAUTION: Testing showed an average breakthrough time of 35.8 minutes with Thiotepa and 12.7 minutes with Carmustine.
WARNING: Do not use with Carmustine and Thiotepa.
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
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/K211022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211022: Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211022
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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