# K202179: Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 26, 2020 after 83 days
- Product code: LYZ (Vinyl 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
The Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between the patient and examiner. The 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 Concentration Minimum Breakthrough Detection Carmustine 3.3 mg/ml 11.4 minutes Cisplatin l.0mg/ml >240 minutes Cyclophosphamide 20.0 mg/ml >240 minutes Dacarbazine 10.0 mg/ml >240 minutes Doxorubicin Hydrocholoride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0mg/ml 17.4 minutes WARNING: DO NOT USE WITH CARMUSTINE DO NOT USE WITH THIOTEPA

Source page: https://510kreport.com/device/K202179
Methodology: https://510kreport.com/methodology