# K200671: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Jun 19, 2020 after 98 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K082457 (2008). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082457: Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use), Ansell Healthcare Products, Inc. (2008) Summary page 6.

## Most influential descendants
- 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 (2021), 2 descendants of its own
- K240080: Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2024), 1 descendant of its own
- K231365: Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves (2024), 1 descendant of its own
- K212148: Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs (2022), 1 descendant of its own
- K250342: Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K200671
Methodology: https://510kreport.com/methodology