# K093726: Mediguard Nitrile Examination Glove- Blue (Tested for Use with Chemotherapy Drugs)

- Pathway: 510(k) (Abbreviated)
- Applicant: Medline Industries, Inc.
- Decided: Feb 22, 2010 after 81 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K102096: Powder Free Nitrile Examination Gloves, Blue (2010), 1 descendant of its own
- K140816: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (2014), 0 descendants of its own

## Indications for use
The Mediguard Powder-Free Nitrite 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: 5-Fluorouracil — >240 min. Etoposide (Toposar) — >240 miii. Cyclophosphamide (Cytoxan) — >240 mini. Carmustine — LiD0 Min. Thiotepa — 8.13 mmn. Paliltaxel (Traxol) — >240 mmn Doxorubicin Hydrochloride — >240 nudn. Dacarbazine (DTIC) — >240 mini. Cisplatin — >240 min. Ifosfamide (Ifex) — >240 min. Miltoxantrone — >240 min. Vincristine Sulfate — >240 mini.

Source page: https://510kreport.com/device/K093726
Methodology: https://510kreport.com/methodology