# K251319: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Jul 30, 2025 after 92 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 K201531 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201531: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), Hartalega Sdn Bhd (2020) Summary page 7.

## Indications for use
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Culff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (3.3 mg/ml) 383 Cisplatin (1.0 mg/ml) > 240 Cyclophosphamide (20.0 mg/ml) > 240 Dacarbazine (10.0 mg/ml) > 240 Doxorubicin HCI (2.0 mg/ml) > 240 Etoposide (20.0 mg/ml) > 240 Fluorouracil (50.0 mg/ml) > 240 Methotrexate (25.0 mg/ml) > 240 Mytomycin C (0.5 mg/ml) > 240 Paclitaxel (6.0 mg/ml) > 240 Thiotepa (10.0 mg/ml) 78.6 Vincristine Sulfate (1.0 mg/ml) > 240 Vidaza (5-Azacytidine), 25 mg/ml >240 Busulfan, 6 mg/ml >240 Carboplatin, 10 mg/ml >240 Docetaxel, 10 mg/ml >240 Epirubicin HCI, 2 mg/ml >240 Gemcitabine HCI, 38 mg/ml >240 Ifosfamide, 50 mg/ml >240 Irinotecan, 20 mg/ml >240 Mitoxantrone HCI, 2 mg/ml >240 Oxaliplatin, 5 mg/ml >240 Vinorelbine, 10 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 38.3 minutes with Carmustine and 78.6 minutes with Thiotepa. Warning: Do not use with Carmustine

Source page: https://510kreport.com/device/K251319
Methodology: https://510kreport.com/methodology