510(k) · Cleared
ClearedMicroflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
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 19, 2020 as substantially equivalent to K082457 (Ansell Healthcare Products, Inc., 2008) after a 98-day review. Its family tree reaches back 1 generation to 2008. 7 later devices descend from it.
- Decided
- Jun 19, 2020
- Review
- 98 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082457 (2008). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK082457 Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination…Ansell Healthcare Products, Inc. · 2008
- This deviceK200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile…Ansell Healthcare Products, LLC · 2020
- Descendant · cites it directly · 2 of its ownK210401 Microflex Nitrile Patient Examination Gloves Blue Colored Tested for…Ansell Healthcare Products, LLC · 2021
- Descendant · cites it directly · 1 of its ownK240080 Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with…Syntex Healthcare Products Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK231365 Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored…Anhui Intco Medical Products Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK212148 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue)…Ansell Healthcare Products, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK250342 Powder-Free Polychloroprene Examination Glove (Green Color) Tested…Encompass Industries Sdn. Bhd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…Ansell Healthcare Products, LLC · 2021 · cites it directly2descendants
- K240080Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and…Syntex Healthcare Products Co., Ltd. · 2024 · cites it directly1descendant
- K231365Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use…Anhui Intco Medical Products Co., Ltd. · 2024 · cites it directly1descendant
- K212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with…Ansell Healthcare Products, LLC · 2022 · 2 generations on1descendant
- K250342Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with…Encompass Industries Sdn. Bhd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082457 | Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves… | Ansell Healthcare Products, Inc. | 2008 | — |
| 0 (this device) | 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 | — |
| +1 | K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy… | Syntex Healthcare Products Co., Ltd. | 2024 | — |
| +1 | K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and… | Anhui Intco Medical Products Co., Ltd. | 2024 | — |
| +2 | K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for… | Ansell Healthcare Products, LLC | 2022 | — |
| +3 | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K082457 | Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy…Summary page 6…e Name: Micro-Touch NitraTex Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) 510(k) Number: K082457 Device Class: Class I Product Code: LZA (Nitrile) Device Name: Patient Examinati… | 2008 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with… | 2021 | 2 |
| K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and… | 2024 | 1 |
| K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use… | 2024 | 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?
- Its one ancestor has no recall.
- Of its descendants, K210401 (Ansell Healthcare Products, LLC, 2021) has gone furthest, with 2 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. 2020, 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 of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test Chemotherapy drug & Concentration — Average Breakthrough…
Read the full statement (471 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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Test Chemotherapy drug & Concentration — Average Breakthrough Detection Time (Minutes)
Carmustine (BCNU) - 3.3 mg/ml — 17.4
Cyclophosphamide - 20.0 mg/ml — >240
Doxorubicin HCI (Adriamycin) 2.0 mg/ml — >240
Etoposide (Toposar)- 20.0 mg/ml — >240
Fluorouracil (Adrucil) - 50.0 mg/ml — >240
Methotrexate - 25.0 mg/ml — >240
Paclitaxel (Taxol) - 6.0 mg/ml — >240
Thiotepa (THT) - 10.0 mg/ml — 67.1
Vincristine Sulfate - 1.0 mg/ml — >240
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 17.4 minutes and Thiotepa: 67.1 minutes. Warning: Do not use with Carmustine.
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 of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Test Chemotherapy drug & Concentration — Average Breakthrough Detection Time (Minutes)
Carmustine (BCNU)- 3.3 mg/ml — 27.9
Cyclophosphamide - 20.0 mg/ml — >240
Doxorubicin HCI (Adriamycin) 2.0 mg/ml — >240
Etoposide (Toposar)- 20.0 mg/ml — >240
Fluorouracil (Adrucil) - 50.0 mg/ml — >240
Methotrexate - 25.0 mg/ml — >240
Paclitaxel (Taxol) - 6.0 mg/ml — >240
Thiotepa (THT) - 10.0 mg/ml — 48.6
Vincristine Sulfate - 1.0 mg/ml — >240
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 27.9 minutes and Thiotepa: 48.6 minutes. Warning: Do not use with Carmustine.
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 of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Test Chemotherapy drug & Concentration — Average Breakthrough Detection Time (Minutes)
Carmustine (BCNU) - 3.3 mg/ml — 23.4
Cyclophosphamide - 20.0 mg/ml — >240
Doxorubicin HCI (Adriamycin) 2.0 mg/ml — >240
Etoposide (Toposar)- 20.0 mg/ml — >240
Fentanyl Citrate Injection - 100 mcg/2mL — >240
Fluorouracil (Adrucil)- 50.0 mg/ml — >240
Methotrexate - 25.0 mg/ml — >240
Paclitaxel (Taxol) - 6.0 mg/ml — >240
Thiotepa (THT) - 10.0 mg/ml — 64.9
Vincristine Sulfate - 1.0 mg/ml — >240
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 23.4 minutes and Thiotepa: 64.9 minutes. Warning: Do not use with Carmustine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200671 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200671: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200671
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