510(k) · Cleared
ClearedGenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genabio Diagnostics, Inc. · LZA Polymer Patient Examination Glove
Cleared on Aug 28, 2024 as substantially equivalent to K192954 (Comfort Rubber Gloves Industries Sdn. Bhd., 2020) after a 183-day review. Its family tree reaches back 2 generations to 2019. 1 later device descends from it.
- Decided
- Aug 28, 2024
- Review
- 183 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183287 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 1 generation backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- This deviceK240545 GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with…Genabio Diagnostics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK242936 Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use…Sunray Medical Products, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242936Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy…Sunray Medical Products, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −1 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| 0 (this device) | K240545 | GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with… | Genabio Diagnostics, Inc. | 2024 | — |
| +1 | K242936 | Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with… | Sunray Medical Products, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 |
|---|---|---|---|
| * | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylSummary page 6…Perak, Malaysia Device Name: Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) Number: K192954 5.0 Device Description The subject device is single use, disposable gloves intended for medical purposes to be worn on the… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242936 | Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy… | 2025 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K242936 (Sunray Medical Products, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K192954.
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?
The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to…
Read the full statement (206 words)
The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
Carmustine 3.3 mg/ml 22.8 Minutes
Cisplatin 1.0 mg/ml > 240 Minutes
Cyclophosphamide 20.0 mg/ml > 240 Minutes
Dacarbazine 10.0 mg/ml > 240 Minutes
Doxorubicin HCI 2.0 mg/ml > 240 Minutes
Etoposide 20.0 mg/ml > 240 Minutes
Fluorouracil 50.0 mg/ml > 240 Minutes
Methotrexate 25.0 mg/ml > 240 Minutes
Mitomycin C 0.5 mg/ml > 240 Minutes
Paclitaxel 6.0 mg/ml > 240 Minutes
Thiotepa 10.0 mg/ml 37.9 Minutes
Vincristine Sulfate 1.0 mg/ml > 240 Minutes
Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time
Fentanyl Citrate Injection 100.0mcg/2ml > 240 Minutes
Please note that the following drugs have low permeation time:
Carmustine 3.3 mg/ml 22.8 Minutes; Thiotepa 10.0 mg/ml 37.9 Minutes
Warning: Do not use with Carmustine and Thiotepa.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240545: GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240545
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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