510(k) · Cleared
ClearedNitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mah Sing Healthcare Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Jun 6, 2025 as substantially equivalent to K240080 (Syntex Healthcare Products Co., Ltd., 2024) after a 189-day review. Its family tree reaches back 3 generations to 2008.
- Decided
- Jun 6, 2025
- Review
- 189 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K082457 (2008). No later device cites it as a predicate yet.
- Root · 3 generations backK082457 Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination…Ansell Healthcare Products, Inc. · 2008
- 2 generations backK200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile…Ansell Healthcare Products, LLC · 2020
- 1 generation backK240080 Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with…Syntex Healthcare Products Co., Ltd. · 2024
- This deviceK243694 Nitrile Powder Free Examination Glove with Tremella Fuciformis…Mah Sing Healthcare Sdn. Bhd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K082457 | Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves… | Ansell Healthcare Products, Inc. | 2008 | — |
| −2 | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue… | Ansell Healthcare Products, LLC | 2020 | — |
| −1 | K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy… | Syntex Healthcare Products Co., Ltd. | 2024 | — |
| 0 (this device) | K243694 | Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested… | Mah Sing Healthcare Sdn. Bhd. | 2025 | — |
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 |
|---|---|---|---|
| * | K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and…Summary page 6…on Gloves (Green) Tested for Predicate Device Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) Number: K240080 Product Code: LZA, LZC, OPJ, QDO Manufacture’s Name: Syntex Healthc… | 2024 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a 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. 2025, 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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Tested Chemotherapy Drugs Concentration Minimum Breakthrough Detection Time in minutes…
Read the full statement (161 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Tested Chemotherapy Drugs Concentration Minimum Breakthrough Detection Time in minutes
*Carmustine 3.3mg/ml 22.5
Cisplatin 1 mg/ml >240
Cyclophosphamide 20 mg/ml >240
Dacarbazine 10 mg/ml >240
Doxorubicin, HCl 2 mg/ml >240
Etoposide 20 mg/ml >240
Fluorouracil 50 mg/ml >240
Methotrexate 25 mg/ml >240
Mitomycin 0.5 mg/ml >240
Oxaliplatin 5 mg/ml >240
Paclitaxel 6 mg/ml >240
*Thiotepa 10 mg/ml 34.5
Vincristine 1 mg/ml >240
Tested Opioid Drugs Concentration Minimum Breakthrough Detection Time in minutes
Fentanyl Citrate Injection 100mcg/2ml >240
Warning: Do not use with Carmustine and Thiotepa.
*Note:
Please note that the following drugs have low permeation times:
(1) Carmustine – 22.5 minutes
(2) Thiotepa – 34.5 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243694: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243694
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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