# K160467: Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Kossan International Sdn Bhd
- Decided: Aug 2, 2016 after 165 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 per ASTM D6978-05 (Reapproved 2013) 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) — 30.1 Cisplatin (1.0 mg/ml) — >240 Cyclophosphamide (Cytoxan) (20 mg/ml) — >240 Cytarabine (100 mg/ml) — >240 Dacarbazine (DTIC) (10.0 mg/ml) — >240 Doxorubicin Hydrochloride (2.0 mg/ml) — >240 Etoposide (20.0 mg/ml) — >240 Fluorouracil (50.0 mg/ml) — >240 Ifosfamide (50.0 mg/ml) — >240 Methotrexate (25 mg/ml) — >240 Mitomycin C (0.5 mg/ml) — >240 Mitoxantrone (2.0 mg/ml) — >240 Paclitaxel (Taxol) (6.0 mg/ml) — >240 Thiotepa (10.0 mg/ml) — 50.5 Vincristine Sulfate (1.0 mg/ml) — >240 Please note that the following drugs have extremely low permeation times of less than 60 minutes: Carmustine (BCNU) (3.3mg/ml): 30.1 minutes Thiotepa (10.0 mg/ml): 50.5 minutes

Source page: https://510kreport.com/device/K160467
Methodology: https://510kreport.com/methodology