# K232461: Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis

- Pathway: 510(k) (Traditional)
- Applicant: Kossan International Sdn Bhd
- Decided: Nov 14, 2023 after 91 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 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Pink Orange Blue Black Carmustine (BCNU) (3.3 mg/ml) 12.4 11.7 10.1 14.4 Cisplatin (1.0 mg/ml) >240 >240 >240 >240 Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240 >240 >240 >240 Cytarabine(100 mg/ml) >240 Not tested >240 >240 Dacarbazine (DTIC) (10.0 mg/ml) >240 >240 >240 >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 >240 >240 >240 Etoposide (20.0 mg/ml) >240 >240 >240 >240 Fluorouracil (50.0 mg/ml) >240 >240 >240 >240 lfosfamide (50.0 mg/ml) >240 Not Tested >240 >240 Methotrexate (25.0 mg/ml) >240 Not Tested >240 >240 Mitomycin C (0.5 mg/ml) >240 Not Tested >240 >240 Mitoxantrone (2.0 mg/ml) >240 Not Tested >240 >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 >240 >240 >240 Thiotepa (10.0 mg/ml) 43.1 43.2 30.2 29.2 Vincristine Sulfate (1.0 mg/ml) >240 Not Tested >240 >240 Please note that Carmustine (BCNU) and Thiotepa has low permeation times. Warning: Do Not Use with Carmustine (BCNU) and Thiotepa Opioid Drug and Concentration Minimum Breakthrough Detection Time in Minutes Pink Orange Blue Black Fentanyl Citrate Injection (100 mcg/2ml) >240 >240 >240 >240 Xylazine HCI (100 mg/ml) Not Tested >240 >240 >240 Simulated Gastric Acid Minimum Breakthrough Detection Time in Minutes Pink Orange Blue Black Simulated Gastric Acid >240 >240 >240 >240

Source page: https://510kreport.com/device/K232461
Methodology: https://510kreport.com/methodology