510(k) · Cleared
ClearedPF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shen Wei USA, Inc. · LZA Polymer Patient Examination Glove
Cleared on Sep 26, 2019 after a 212-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 26, 2019
- Review
- 212 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. 2019, 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. Tested for use with chemotherapy drugs and Fentanyl Citrate. White-Black Black-Gray Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes Carmustine (BONU), 3.3mg/m] 278 27.1 Cisplatin, 1.0mg/mi =240 =240 Cyclophosphamide (Cytoxan), 20mg/ml =240 =240 Cyclosporin A, 100 mg/ml =240 not tested…
Read the full statement (145 words)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs and Fentanyl Citrate.
White-Black Black-Gray
Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes
Carmustine (BONU), 3.3mg/m] 278 27.1
Cisplatin, 1.0mg/mi =240 =240
Cyclophosphamide (Cytoxan), 20mg/ml =240 =240
Cyclosporin A, 100 mg/ml =240 not tested
Dacarbazine (DTIC) 10g mg/ml >240 =240
Doxorubicin Hydrochloride, 2.0 mg/ml =240 =240
Etoposide (Toposar), 20mg/ml =240 =240
Fluorouracil S0mg/ml >240 =240
Paclitaxel (Taxol), 6.0mg/'ml =240 =240
Thioteps, 10mg/ml 779 274
Vincristine Sulfate, 1. Omg/mi >240 not tested
Fentany! Citrate, 100mcg/2ml =240 =240
WARNING: Do not use with Carmustine and Thiotepa.
Please note that Carmustine (BCNU) has low permeation of 27.8 minutes for White-Black color and 27.1 minutes for Black-Gray color; Thiotepa has 77.9 minutes for White-Black color and 27.4 minutes for Black-Gray color.
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/K190466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190466: PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190466
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