# K090568: Medline Nitrile Exam Gloves W/Aloe -Green

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 2, 2009 after 213 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
The Medline Powder-Free Nitrile Examination Glove with Aloe (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 — 19.31 min. Thiotepa — 26.88 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. WARNING: Do not use with Carmustine and Thio-Tepa.

Source page: https://510kreport.com/device/K090568
Methodology: https://510kreport.com/methodology