510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zibo Lanhua Medical Packaging Material Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Dec 4, 2022 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 4, 2022
- Review
- 76 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. 2022, 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?
The Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test…
Read the full statement (540 words)
The Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
*Carmustine 3.3 mg/ml (3,300 ppm) 21.1
Cisplatin 1.0 mg/ml(l,000 ppm) >240
Cyclophosphamide 20 mg/ml(20,000 ppm) >240
Dacarbazine 10 mg/ml(l 0,000 ppm) >240
Doxorubicin HCl 2.0 mg/ml(2,000 ppm) >240
Etoposide 20.0 mg/ml(20,000 ppm) >240
Fluorouracil 50.0 mg/m1(50,000 ppm) >240
Mechlorethamine HCl 1 mg/ml (1,000 ppm) >240
Methotrexate 25.0 mg/m1(25,000 ppm) >240
Mitomycin C 0.5 mg/m1(500 ppm) >240
Paclitaxel 6.0 mg/ml(6,000 ppm) >240
*Thio Tepa 10.0 mg/ml(l0,000 ppm) 43.3
Vincristine Sulfate 1.0 mg/ml(l,000 ppm) >240
Fentanyl Citrate Injection 100mcg/2ml >240
Please note that the following drugs have low permeation times:
Carmustine 3.3mg/ml 21.1 Minutes
Thiotepa 10.0 mg/ml 43.3 Minutes
Warning: Don't use with either Carmustine or Thiotepa
The Powder Free Nitrile Examination Gloves, White,Test For Use With Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
*Carmustine 3.3 mg/ml (3,300 ppm) 11.9
Cisplatin 1.0 mg/ml(1,000 ppm) >240
Cyclophosphamide 20 mg/ml(20,000 ppm) >240
Dacarbazine 10 mg/ml(10,000 ppm) >240
Doxorubicin HCI 2.0 mg/ml(2,000 ppm) >240
Etoposide 20.0 mg/ml(20,000 ppm) >240
Fluorouracil 50.0 mg/ml(50,000 ppm) >240
Mechlorethamine HCl 1 mg/ml (1,000 ppm) >240
Methotrexate 25.0 mg/ml(25,000 ppm) >240
Mitomycin C 0.5 mg/ml(500 ppm) >240
Paclitaxel 6.0 mg/ml(6,000 ppm) >240
*Thio Tepa 10.0 mg/ml(10,000 ppm) 33.0
Vincristine Sulfate 1.0 mg/ml(1,000 ppm) >240
Fentanyl Citrate Injection 100mcg/2ml >240
Please note that the following drugs have low permeation times:
Carmustine 3.3mg/ml 11.9 Minutes
Thiotepa 10.0 mg/ml 33.OMinutes.
Warning: Don't use with either Carmustine or Thiotepa
The Powder Free Nitrile Examination Gloves, Black,Test For Use With Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
*Carmustine 3.3 mg/ml (3,300 ppm) 11.3
Cisplatin 1.0 mg/ml(1,000 ppm) >240
Cyclophosphamide 20 mg/ml(20,000 ppm) >240
Dacarbazine 10 mg/ml(10,000 ppm) >240
Doxorubicin HCI 2.0 mg/ml(2,000 ppm) >240
Etoposide 20.0 mg/ml(20,000 ppm) >240
Fluorouracil 50.0 mg/ml(50,000 ppm) >240
Mechlorethamine HCI 1 mg/ml (1,000 ppm) >240
Methotrexate 25.0 mg/ml(25,000 ppm) >240
Mitomycin C 0.5 mg/ml(500 ppm) >240
Paclitaxel 6.0 mg/ml(6,000 ppm) >240
*Thio Tepa 10.0 mg/ml(10,000 ppm) 28.7
Vincristine Sulfate 1.0 mg/ml(1,000 ppm) >240
Fentanyl Citrate Injection 100mcg/2ml >240
Please note that the following drugs have low permeation times:
Carmustine 3.3mg/ml 11.3 Minutes
Thiotepa 10.0 mg/ml 28.7 Minutes.
Warning: Don't use with either Carmustine or Thiotepa
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K222815 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222815: Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222815
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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