510(k) · Cleared
ClearedBiodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sw Technologies, Inc. · LZA Polymer Patient Examination Glove
Cleared on Jun 24, 2026 after a 352-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 24, 2026
- Review
- 352 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. 2026, 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 disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Chemotherapy Drug and Concentration Breakthrough times in minutes per ASTM D6978-05 (2019) Carmustine (BCNU), 3.3mg/ml 86.3 Cisplatin, 1.0mg/ml >240 Cyclophosphamide (Cytoxan), 20mg/ml >240 Dacarbazine (DTIC) 10g mg/ml >240 Doxorubicin Hydrochloride, 2.0 mg/ml >240 Etoposide (Toposar), 20mg/ml >240 Fluorouracil…
Read the full statement (227 words)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between
patient and examiner.
Chemotherapy Drug and Concentration Breakthrough times in minutes per ASTM D6978-05 (2019)
Carmustine (BCNU), 3.3mg/ml 86.3
Cisplatin, 1.0mg/ml >240
Cyclophosphamide (Cytoxan), 20mg/ml >240
Dacarbazine (DTIC) 10g mg/ml >240
Doxorubicin Hydrochloride, 2.0 mg/ml >240
Etoposide (Toposar), 20mg/ml >240
Fluorouracil 50mg/ml >240
Paclitaxel (Taxol), 6.0mg/ml >240
Thiotepa, 10mg/ml 89.3
Bleomycin Sulfate,15 mg/ml (15,000 ppm) >240
Busulfan,6 mg/ml (6,000 ppm) >240
Carboplatin, 10 mg/ml (10,000 ppm) >240
Cytarabine, 100 mg/ml (100,000 ppm) >240
Daunorubicin HCI,5 mg/ml (5,000 ppm) >240
Docetaxel HCI, 10 mg/ml (10,000 ppm) >240
Epirubicin HCI (Ellence),2 mg/ml (2,000 ppm) >240
Fludarabine Phosphate,25 mg/ml (25,000 ppm) >240
Gemcitabine HCIL,38 mg/ml (38,000 ppm) >240
Idarubicin HCI,1 mg/ml (1,000 ppm) >240
Mechlorethamine HCI,1 mg/ml (1,000 ppm) >240
Melphalan HCL5 mg/ml (5,000 ppm) >240
Methotrexate,25 mg/ml (25,000 ppm) >240
Mitomycin C,0.5 mg/ml (500 ppm) >240
Mitoxantrone HCL,2 mg/ml (2,000 ppm) >240
Oxaliplatin,2 mg/ml (2,000 ppm) >240
Rituximab, 10 mg/ml (10,000 ppm) >240
Trisenox (Arsenic Trioxide), 1 mg/ml (1,000 ppm) >240
Vincristine Sulfate,1 mg/ml (1,000 ppm) >240
Vinorelbine, 10 mg/ml (10,000 ppm) >240
Ifosfamide (50.0 mg/ml) >240
Irinotecan (20.0 mg/ml) >240
Fentanyl Citrate 100mcg/2ml >240
Simulated Gastric Acid >240
Fentanyl-Simulated Gastric Acid Solution 50/50 >240
Caution: Please note low permeation times for Carmustine at 86.3 minutes and Thiotepa at §9.3 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/K252117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252117: Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252117
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026