# K260794: NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR

- Pathway: 510(k) (Traditional)
- Applicant: Kossan International Sdn Bhd
- Decided: Aug 18, 2026 after 160 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A 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. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (BCNU) (3.3 mg/ml) 10.0 Cisplatin (1 mg/ml) >240 Cyclophosphamide (Cytoxan) (20 mg/ml) >240 Cytarabine (100 mg/ml) >240 Dacarbazine (DTIC) (10 mg/ml) >240 Doxorubicin Hydrochloride (2 mg/ml) >240 Etoposide (20 mg/ml) >240 Fluorouracil (50 mg/ml) >240 Ifosfamide (50 mg/ml) >240 Methotrexate (25 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2 mg/ml) >240 Paclitaxel (Taxol) (6 mg/ml) >240 Thiotepa (10 mg/ml) 20.0 Vincristine Sulfate (1 mg/ml) >240 Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 10.0 and 20.0 minutes respectively. Warning: Do Not Use with Carmustine (BCNU) and Thiotepa Opioid and Concentration Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100 mcg/2ml) >240 Xylazine HCI and Concentration Minimum Breakthrough Detection Time in Minutes Xylazine HCI (100 mg/ml) >240 Simulated Gastric Acid Fluid Minimum Breakthrough Detection Time in Minutes Simulated Gastric Acid Fluid >240

Source page: https://510kreport.com/device/K260794
Methodology: https://510kreport.com/methodology