# K243818: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

- Pathway: 510(k) (Special)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Jan 8, 2025 after 27 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 K151997 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222225: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue), Hartalega NGC Sdn. Bhd. (2022) Summary page 6.

## Indications for use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) 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 and fentanyl citrate as per ASTM 06978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine, 3.3 mg/ml 10.2 Cisplatin, 1.0 mg/ml >240 Cyclophosphamide, 20.0 mg/ml >240 Dacarbazine, 10.0 mg/ml >240 Doxorubicin Hydrochloride, 2.0 mg/ml >240 Etoposide, 20.0 mg/ml >240 Fluorouracil, 50.0 mg/ml >240 Methotrexate, 25.0 mg/ml >240 Mitomycin C, 0.5 mg/ml >240 Paclitaxel, 6.0 mg/ml >240 Thiotepa, 10.0 mg/ml 30.2 Vincristine Sulfate, 1.0 mg/ml >240 Bleomycin Sulfate, 15.0 mg/ml >240 Bortezomib, 1.0 mg/ml >240 Busulfan, 6.0 mg/ml >240 Carboplatin, 10.0 mg/ml >240 Chloroquine, 50.0 mg/ml >240 Cyclosporin A, 100.0 mg/ml >240 Cytarabine, 100.0 mg/ml >240 Daunorubicin, 5.0 mg/ml >240 Docetaxel, 10.0 mg/ml >240 Epirubicin, 2.0 mg/ml >240 Fludarabine, 25.0 mg/ml >240 Gemcitabine, 38.0 mg/ml >240 Idarubicin, 1.0 mg/ml >240 Ifosfamide, 50.0 mg/ml >240 Irinotecan, 20.0 mg/ml >240 Mechlorethamine HCI, 1.0 mg/ml >240 Melphalan, 5.0 mg/ml >240 Mitoxantrone, 2.0 mg/ml >240 Oxaliplatin, 2.0 mg/ml >240 Paraplatin, 1u.u mg/ml >240 Retrovir, 10.0 mg/ml >240 Rituximab, 10.0 mg/ml >240 Topotecan, 1.0 mg/ml >240 Trisenox, 1.0 mg/ml > 240 Fentanyl Citrate and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection, 100mcg/2ml >240 Caution: Testing showed a minimum breakthrough time of 10.2 minutes with Carmustine and 30.2 minutes with Thiotepa. Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K243818
Methodology: https://510kreport.com/methodology