# K103602: Eudermic MP Latex Examination Glove-Blue (Tested for Use with Chemotherapy Drugs) W/ a Protein Content Label Claim

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Apr 21, 2011 after 134 days
- Product code: LYY (Latex 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. The FDA summary names no predicate by number.

## Indications for use
The Eudermic MP Powder-Free Latex Examination Glove (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: Chemotherapy Drug — Average BDT 5-Fluorouracil — >240 min. Etoposide (Toposar) — >240 min. Cyclophosphamide (Cytoxan) — >240 min. Carmustine — 6.26 min. Thiotepa — 12.13 min. Paclitaxel (Taxol) — >240 min. Doxorubicin Hydrochloride — >240 min. Dacarbazine (DTIC) — >240 min. Cisplatin — >240 min. Ifosfamide (Ifex) — >240 min. Mitoxantrone — >240 min. Vincristine Sulfate — >240 min. Please note that the following drugs have extremely low permeation times: * Carmustine — 6.26 minutes * Thiotepa — 12.13 minutes

Source page: https://510kreport.com/device/K103602
Methodology: https://510kreport.com/methodology