510(k) · Cleared
ClearedMicroflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored 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
Ansell Healthcare Products, LLC · LZA Polymer Patient Examination Glove
Cleared on Jun 13, 2021 as substantially equivalent to K200671 (Ansell Healthcare Products, LLC, 2020) after a 123-day review. Its family tree reaches back 2 generations to 2008. 2 later devices descend from it.
- Decided
- Jun 13, 2021
- Review
- 123 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082457 (2008). 2 later devices descend 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 deviceK210401 Microflex Nitrile Patient Examination Gloves Blue Colored Tested for…Ansell Healthcare Products, LLC · 2021
- Descendant · cites it directly · 1 of its ownK212148 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue)…Ansell Healthcare Products, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK250342 Powder-Free Polychloroprene Examination Glove (Green Color) Tested…Encompass Industries Sdn. Bhd. · 2025
Most influential descendants
Showing 2 of 2 · See all- K212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with…Ansell Healthcare Products, LLC · 2022 · cites it directly1descendant
- K250342Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with…Encompass Industries Sdn. Bhd. · 2025 · 2 generations on0descendants
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) | 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 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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…momile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) Number: K200671 Device Class: Class I Product Code: LZA, LZC, QDO Device Name: Patient Examinati… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with… | 2022 | 1 |
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 13 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K212148 (Ansell Healthcare Products, LLC, 2022) has gone furthest, with 1 descendant 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. 2021, 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 and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 47.9…
Read the full statement (453 words)
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 and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 47.9 minutes. Warning: Do not use with Carmustine.
Tested chemotherapy drugs are as follows:
Carmustine - 3.3 mg/ml: 47.9 minutes
Cyclophosphamide - 20.0 mg/ml: >240 minutes
Doxorubicin HCl - 2.0 mg/ml: >240 minutes
Etoposide - 20.0 mg/ml: >240 minutes
Fentanyl Citrate Injection - 100 mcg/2 ml: >240 minutes
Fluorouracil - 50.0 mg/ml: >240 minutes
Methotrexate - 25.0 mg/ml: >240 minutes
Paclitaxel - 6.0 mg/ml: >240 minutes
Thiotepa - 10.0 mg/ml: >240 minutes
Vincristine Sulfate - 1.0 mg/ml: >240 minutes
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 and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 49.6 minutes. Warning: Do not use with Carmustine.
Tested chemotherapy drugs are as follows:
Carmustine - 3.3 mg/ml: 49.6 minutes
Cisplatin - 1.0 mg/ml: >240 minutes
Cyclophosphamide - 20.0 mg/ml: >240 minutes
Dacarbazine - 10.0 mg/ml: >240 minutes
Doxorubicin HCl - 2.0 mg/ml: >240 minutes
Etoposide - 20.0 mg/ml: >240 minutes
Fentanyl Citrate Injection - 100 mcg/2 ml: >240 minutes
Fluorouracil - 50.0 mg/ml: >240 minutes
Methotrexate - 25.0 mg/ml: >240 minutes
Paclitaxel - 6.0 mg/ml: >240 minutes
Thiotepa - 10.0 mg/ml: >240 minutes
Vincristine Sulfate - 1.0 mg/ml: >240 minutes
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 and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 27.6 minutes. Warning: Do not use with Carmustine.
Tested chemotherapy drugs are as follows:
Carmustine - 3.3 mg/ml: 27.6 minutes
Cyclophosphamide - 20.0 mg/ml: >240 minutes
Doxorubicin HCl - 2.0 mg/ml: >240 minutes
Etoposide - 20.0 mg/ml: >240 minutes
Fentanyl Citrate Injection - 100 mcg/2 ml: >240 minutes
Fluorouracil - 50.0 mg/ml: >240 minutes
Methotrexate - 25.0 mg/ml: >240 minutes
Paclitaxel - 6.0 mg/ml: >240 minutes
Thiotepa - 10.0 mg/ml: >240 minutes
Vincristine Sulfate - 1.0 mg/ml: >240 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210401: Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored 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/K210401
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