# K250861: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Oct 23, 2025 after 216 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 K200019 (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)
- K200019: Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Hartalega NGC Sdn. Bhd. (2020) Summary page 7.

## Indications for use
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) 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, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid. The gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Concentration Minimum Breakthrough Detection Time in Minutes Azacytidine (25.0 mg/ml) >240 Carmustine (3.3 mg/ml) 25.0 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Carboplatin (10.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Docetaxel (10.0 mg/ml) >240 Doxorubicin HCl (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 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 Oncovin (1.0mg/ml) >240 Oxaliplatin (5.0 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 55.7 Vinorelbine (10.0 mg/ml) >240 Vincristine Sulfate (1.0 mg/ml) >240 Testing showed a minimum breakthrough time of 25.0 minutes with Carmustine and 55.7 minutes with Thiotepa Warning: Do not use with Carmustine Fentanyl Citrate Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection, 100 mcg/2ml >240 Fentanyl Citrate mixed with Simulated Gastric Acid at a 50:50 ratio >240

Source page: https://510kreport.com/device/K250861
Methodology: https://510kreport.com/methodology