# 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

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Jun 13, 2021 after 123 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: 2 generations back to K082457 (2008). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200671: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for, Ansell Healthcare Products, LLC (2020) Summary page 6.

## Most influential descendants
- 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 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

Source page: https://510kreport.com/device/K210401
Methodology: https://510kreport.com/methodology