510(k) · Cleared
ClearedDual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eco Medi Glove Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Jul 19, 2022 after a 110-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 19, 2022
- Review
- 110 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?
A Powder Free patient examination glove 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 for use with chemotherapy drug and Fentanyl Test Claim. In addition these gloves were tested for use with Chemotherapy drug and Fentanyl Citrate Tested claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by…
Read the full statement (203 words)
A Powder Free patient examination glove 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 for use with chemotherapy drug and Fentanyl Test Claim. In addition these gloves were tested for use with Chemotherapy drug and Fentanyl Citrate Tested claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drug and Fentanyl Citrate Tested Claim.
Chemotherapy Drugs and Concentration Minimum Breakthrough Detection Time(Min), ug/cm2/minute
1) Carmustine (BCNU) 3.3mg/ml 28.8 minutes
2) Cyclophosphamide (Cytoxan) (20mg/ml) >240 minutes
3) Cytarabine HCI (100mg/ml) >240 minutes
4) Doxorubicin HCI (2.Omg/ml) >240 minutes
5) Etoposide (20.0mg/mi >240 minutes
6) Fluorouracil (50.0mg/ml) >240 minutes
7) Methotrexate (25mg/ml) >240 minutes
8) Paclitaxel (6.0mg/ml) >240 minutes
9) ThioTepa (10.0mg/ml) 57.6 minutes
10) Fentanyl Citrate Injection 100mg/2mi >240 minute
The Maximum testing time is 240 minutes. Please note that the following drugs have extremely low Permeation time,
Carmustine (BSNU) 3.3mg/ml
Thio Tepa (10.Omg/ml)
WARNING: Not for use with Carmustine or Thio Tepa
Tested for use with Chemotherapy Drugs using ASTM D6978-05. Gloves used for protection against chemotherapy drug exposure must be selected specifically for the type of drugs being used.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K220943 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220943: Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220943
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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