510(k) · Cleared
ClearedNitrile Powder Free Examination Gloves Biodegradable (Green)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comfort Rubber Gloves Industries Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Oct 25, 2024 as substantially equivalent to K192111 (Top Glove Sdn. Bhd., 2020) after a 268-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Oct 25, 2024
- Review
- 268 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K192111 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK192111 Biodegradable Nitrile Examination Powder Free Glove, GreenTop Glove Sdn. Bhd. · 2020
- This deviceK240269 Nitrile Powder Free Examination Gloves Biodegradable (Green)Comfort Rubber Gloves Industries Sdn. Bhd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K192111 | Biodegradable Nitrile Examination Powder Free Glove, Green | Top Glove Sdn. Bhd. | 2020 | — |
| 0 (this device) | K240269 | Nitrile Powder Free Examination Gloves Biodegradable (Green) | Comfort Rubber Gloves Industries 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 |
|---|---|---|---|
| * | K192111 | Biodegradable Nitrile Examination Powder Free Glove, GreenSummary page 5…Predicate Device Device Name: Biodegradable Nitrile Examination Powder Free Glove, Green Company: Top Glove SDN BHD 510(K) No.: K192111 4.0 Description of the Device: Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the re… | 2020 |
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?
- Its one ancestor has no 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. 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 Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a
disposable device intended for medical purposes that is worn on the examiner's hand or finger to
prevent contamination between examiner and patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240269: Nitrile Powder Free Examination Gloves Biodegradable (Green).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240269
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