510(k) · Cleared
ClearedNon-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare Products, LLC · LZA Polymer Patient Examination Glove
Cleared on Mar 10, 2022 as substantially equivalent to K210401 (Ansell Healthcare Products, LLC, 2021) after a 244-day review. Its family tree reaches back 3 generations to 2008. 1 later device descends from it.
- Decided
- Mar 10, 2022
- Review
- 244 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K082457 (2008). 1 later device descends from it, 1 citing it directly.
- 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 backK210401 Microflex Nitrile Patient Examination Gloves Blue Colored Tested for…Ansell Healthcare Products, LLC · 2021
- This deviceK212148 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue)…Ansell Healthcare Products, LLC · 2022
- Descendant · cites it directly · 0 of its ownK250342 Powder-Free Polychloroprene Examination Glove (Green Color) Tested…Encompass Industries Sdn. Bhd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250342Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with…Encompass Industries Sdn. Bhd. · 2025 · cites it directly0descendants
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 | K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with… | Ansell Healthcare Products, LLC | 2021 | — |
| 0 (this device) | K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for… | Ansell Healthcare Products, LLC | 2022 | — |
| +1 | K250342 | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use… | Encompass Industries 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 |
|---|---|---|---|
| * | K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…Summary page 4…trile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) Number: K210401 Device Class: Class I Product Code: LZA, LZC, QDO Device Name: Patient Exa… | 2021 |
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 |
|---|---|---|---|
| K250342 | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with… | 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 14 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K250342 (Encompass Industries Sdn. Bhd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 powder-free 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. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drugs have extremely low permeation times: Carmustine: 45.4 minutes and Thiotepa: 23.5 minutes. Warning: Do not use with Carmustine or Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212148: Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212148
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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