# K223437: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: May 17, 2023 after 184 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 K200581 (2020). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200581: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), Hartalega NGC Sdn. Bhd. (2020) Summary page 6.

## Most influential descendants
- K232070: Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) (2023), 0 descendants of its own

## Indications for use
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes 5-Azacytidine (25.0 mg/ml) > 240 Carboplatin (10.0 mg/ml) > 240 Carmustine (3.3 mg/ml) 12.1 Cisplatin (1.0 mg/ml) > 240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240 Dacarbazine (10.0 mg/ml) > 240 Doxetacel (10.0 mg/ml) > 240 Doxorubicin HCI (2.0 mg/ml) > 240 Epirubicin (2.0 mg/ml) > 240 Etoposide (20.0 mg/ml) > 240 Fluorouracil (50.0 mg/ml) > 240 Gemcitabine (38.0 mg/ml) > 240 Ifosfamide (50.0 mg/ml) > 240 Irinotecan (20.0 mg/ml) > 240 Methotrexate (25.0 mg/ml) > 240 Mitomycin C (0.5 mg/ml) > 240 Mitoxantrone (2.0 mg/ml) > 240 Oxalipatin (5.0 mg/ml) > 240 Paclitaxel (6.0 mg/ml) > 240 Thiotepa (10.0 mg/ml) 37.8 Vincristine Sulfate (1.0 mg/ml) > 240 Oncovin (1.0 mg/ml) > 240 Vinorelbine (10.0mg/ml) > 240 Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100mcg/2ml) >240 Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 12.1 minutes and 37.8 minutes. Warning: Do not use with Carmustine.

Source page: https://510kreport.com/device/K223437
Methodology: https://510kreport.com/methodology