510(k) · Cleared
ClearedAloe Vera Nitrile Examination Gloves (Green) 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
Syntex Healthcare Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Apr 2, 2024 as substantially equivalent to K200671 (Ansell Healthcare Products, LLC, 2020) after an 82-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Apr 2, 2024
- Review
- 82 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082457 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK082457 Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination…Ansell Healthcare Products, Inc. · 2008
- 1 generation backK200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile…Ansell Healthcare Products, LLC · 2020
- This deviceK240080 Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with…Syntex Healthcare Products Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK243694 Nitrile Powder Free Examination Glove with Tremella Fuciformis…Mah Sing Healthcare Sdn. Bhd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243694Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use…Mah Sing Healthcare Sdn. Bhd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082457 | Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves… | Ansell Healthcare Products, Inc. | 2008 | — |
| −1 | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue… | Ansell Healthcare Products, LLC | 2020 | — |
| 0 (this device) | K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy… | Syntex Healthcare Products Co., Ltd. | 2024 | — |
| +1 | K243694 | Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested… | Mah Sing Healthcare Sdn. Bhd. | 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 |
|---|---|---|---|
| * | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink…Summary page 6…Healthcare Products LLC. Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K200671) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, Product Co… | 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 |
|---|---|---|---|
| K243694 | Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use… | 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 16 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243694 (Mah Sing Healthcare Sdn. Bhd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K200671.
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 glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019) The following chemicals have been tested with these gloves: Chemotherapy Drug Minimum Breakthrough Detection Time in Minutes Carmustine 3.3 mg/ml (3,300 ppm) 21.2 Cisplatin, Img/ml (1000 ppm) >240…
Read the full statement (159 words)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
The following chemicals have been tested with these gloves:
Chemotherapy Drug Minimum Breakthrough Detection Time in Minutes
Carmustine 3.3 mg/ml (3,300 ppm) 21.2
Cisplatin, Img/ml (1000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Dacarbazine, 10 mg/ml (10,000 ppm) >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240
Etoposide, 20 mg/ml (20,000 ppm) >240
Fluorouracil (5 Flu), 50mg/ml (50,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Mitomycin C, 0.5mg/ml (500 ppm) >240
Paclitaxel, 6mg/ml (6,000ppm) >240
Thiotepa, 10mg/ml (10,000ppm) 24.9
Vincristine sulfate, 1mg/ml (1000 ppm) >240
Fentanyl Citrate Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection, 100mcg/2mg >240
*Please note that the following drugs have extremely low permeation times:
Carmustine: 21.2 minutes, Thio Tepa: 24.9minutes
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/K240080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240080: Aloe Vera Nitrile Examination Gloves (Green) 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/K240080
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026