# K122464: Midas Touch, Nitrile Examination Gloves, Powder-Free, Orange

- Pathway: 510(k) (Traditional)
- Applicant: Industrial Clothings, Ltd.
- Decided: Apr 12, 2013 after 242 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 powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Cloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.

Source page: https://510kreport.com/device/K122464
Methodology: https://510kreport.com/methodology