510(k) · Cleared
ClearedCornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
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 Feb 7, 2024 as substantially equivalent to K103249 (Cardinal Health, Inc., 2010) after a 152-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Feb 7, 2024
- Review
- 152 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022765 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- 1 generation backK103249 Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested…Cardinal Health, Inc. · 2010
- This deviceK232764 Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use…Eco Medi Glove Sdn. Bhd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| −1 | K103249 | Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use… | Cardinal Health, Inc. | 2010 | — |
| 0 (this device) | K232764 | Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with… | Eco Medi Glove Sdn. Bhd. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103249 | Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use with…Summary page 7…K232764 4.0 Identification of The Legally Marketed Device: Predicate Device: K103249, Cornflower Blue Powder-Free Exam Gloves with Tested for Use with Chemotherapy Drug Labeling Claim Reference Device:… | 2010 |
| † | K220375 | Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free… | 2022 |
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.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K103249.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. It is for over-the- counter use. In addition, these gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05, Standards Practice for…
Read the full statement (201 words)
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. It is for over-the- counter use.
In addition, these gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05, Standards Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Drug Concentration — Minimum Breakthrough detection time in Minutes
Carmustine (3.3mg/ml or 3000ppm) — 15.4 minutes
Cyclophosphamide (20mg/ml or 20,000ppm) — >240 minutes
Cytarabine (100mg/ml) — >240 minutes
Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm) — >240 minutes
Etoposide (20mg/ml or 20,000ppm) — >240 minutes
Flourouracil (50mg/ml or 50,000) — >240 minutes
Methorexate (25mg/ml or 25,000ppm) — >240 minutes
Paclitaxel (6mg/ml or 6,000ppm) — >240 minutes
Thiotepa (10mg/ml or 10,000ppm) — 56.2 minutes
Fentanyl Citrate Injection (100mg/2ml) — >240 minutes
The maximum testing time is 240 minutes.
Please note that the following drugs have extremely low permeation time.
- Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 15.4 minutes.
- Thiotepa (10ug/ml) – Minimum Breakthrough detection time 56.2 minutes.
WARNING: Not for use with Carmustine and ThioTepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232764: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy 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/K232764
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026