# K223375: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

- Pathway: 510(k) (Traditional)
- Applicant: Kossan International Sdn Bhd3
- Decided: Mar 15, 2023 after 131 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 Bendamustine HCI (Treanda) (5 mg/ml): >240 Bleomycin Sulfate (15 mg/ml): >240 Busulfan (6 mg/ml): >240 Carboplatin (10 mg/ml): >240 Carfilzomib (2 mg/ml): >240 Carmustine (BCNU) (3.3 mg/ml): 26.2 Cetuximab (Erbitux) (2 mg/ml): >240 Cisplatin (1 mg/ml): >240 Cladribine (1 mg/ml): >240 Cyclosporin A (100 mg/ml): >240 Cyclophosphamide (Cytoxan) (20 mg/ml): >240 Cytarabine (100 mg/ml): >240 Cytovene (Ganciclovir) (10 mg/ml): >240 Dacarbazine (DTIC) (10 mg/ml): >240 Daunorubicin HCI (5 mg/ml): >240 Decitabine (5 mg/ml): >240 Docetaxel (Taxotere) (20 mg/ml): >240 Doxorubicin Hydrochloride (2 mg/ml): >240 Epirubicin HCI (Ellence) (2 mg/ml): >240 Etoposide (20 mg/ml): >240 Fludarabine (25 mg/ml): >240 Fluorouracil (50 mg/ml): >240 Gemcitabine (38 mg/ml): >240 Idarubicin HCI (1 mg/ml): >240 Ifosfamide (50 mg/ml): >240 Irinotecan (20 mg/ml): >240 Mechlorethamine HCI (1 mg/ml): >240 Melphalan (5 mg/ml): >240 Methotrexate (25 mg/ml): >240 Mitomycin C (0.5 mg/ml): >240 Mitoxantrone (2 mg/ml): >240 Oxaliplatin (5 mg/ml): >240 Paclitaxel (Taxol) (6 mg/ml): >240 Pemetrexed (25 mg/ml): >240 Raltitrexed (0.5 mg/ml): >240 Retrovir (Zidovudine) (10 mg/ml): >240 Rituximab (10 mg/ml): >240 Thiotepa (10 mg/ml): 59.1 Topotecan (1 mg/ml): >240 Trisenox (Arsenic Trioxide) (1 mg/ml): >240 Velcade (Bortezomib) (1 mg/ml): >240 Vidaza (Azacytidine) (25 mg/ml): >240 Vinblastine (1 mg/ml): >240 Vincristine Sulfate (1 mg/ml): >240 Vinorelbine (10 mg/ml): >240 Zoledronic Acid (1 mg/25ml): >240 Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 26.2 and 59.1 minutes respectively. Warning: Do Not Use with Carmustine (BCNU) Caution: Thiotepa has low permeation times of 59.1 minutes Opioid and Concentration — Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection (100 mcg/2ml): >240 Simulated Gastric Acid Fluid — Minimum Breakthrough Detection Time in Minutes Simulated Gastric Acid Fluid: >240

Source page: https://510kreport.com/device/K223375
Methodology: https://510kreport.com/methodology