510(k) · Cleared
ClearedPowder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encompass Industries Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Jul 8, 2025 as substantially equivalent to K212148 (Ansell Healthcare Products, LLC, 2022) after a 152-day review. Its family tree reaches back 4 generations to 2008.
- Decided
- Jul 8, 2025
- Review
- 152 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K082457 (2008). No later device cites it as a predicate yet.
- Root · 4 generations backK082457 Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination…Ansell Healthcare Products, Inc. · 2008
- 3 generations backK200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile…Ansell Healthcare Products, LLC · 2020
- 2 generations backK210401 Microflex Nitrile Patient Examination Gloves Blue Colored Tested for…Ansell Healthcare Products, LLC · 2021
- 1 generation backK212148 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue)…Ansell Healthcare Products, LLC · 2022
- This deviceK250342 Powder-Free Polychloroprene Examination Glove (Green Color) Tested…Encompass Industries Sdn. Bhd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K082457 | Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves… | Ansell Healthcare Products, Inc. | 2008 | — |
| −3 | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue… | Ansell Healthcare Products, LLC | 2020 | — |
| −2 | K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with… | Ansell Healthcare Products, LLC | 2021 | — |
| −1 | K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for… | Ansell Healthcare Products, LLC | 2022 | — |
| 0 (this device) | K250342 | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use… | Encompass Industries 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 |
|---|---|---|---|
| * | K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with…Summary page 6…: Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs 510(k) number : K212148 Company : Ansell Healthcare Products LLC Reference Device : Powder-Free Nitrile Examination Glove (… | 2022 |
| † | K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and… | 2022 |
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 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 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 powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile. The following chemotherapy drugs have been tested on the glove: Chemotherapy Drugs Concentration Breakthrough Detection Time…
Read the full statement (158 words)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on examiner's hand to prevent contamination between patient and examiner. In addition, the glove was evaluated using ASTM D6978 for permeation of chemotherapy drugs and fentanyl citrate. The glove is single use and non-sterile.
The following chemotherapy drugs have been tested on the glove:
Chemotherapy Drugs Concentration Breakthrough Detection Time
Carmustine* 3.3 mg/mL 23.2 min
Cisplatin 1.0 mg/mL >240 min
Cyclophosphamide 20.0 mg/mL >240 min
Dacarbazine 10.0 mg/mL >240 min
Doxorubicin HCL 2.0 mg/mL >240 min
Etoposide 20.0 mg/mL >240 min
Fluorouracil 50.0 mg/mL >240 min
Methotrexate 25.0 mg/mL >240 min
Paclitaxel 6.0 mg/mL >240 min
ThioTepa* 10.0 mg/mL 13.5 min
Mitomycin C 0.5 mg/mL >240 min
Vincristine Sulfate 1.0 mg/mL >240 min
Fentanyl
Fentanyl Citrate 100.0 meg/2mL >240 min
*Please note that the following drugs have low permeation time.
1. Carmustine
2. ThioTepa
Warning: Do not use with Carmustine & 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/K250342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250342: Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250342
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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