# K040108: Opue-E Disposable Powder Free Vinyl Synthetic Exam Gloves with Vitamin Complex, Nopal and Lanolin

- Pathway: 510(k) (Traditional)
- Applicant: Est International Corporation
- Decided: Aug 17, 2004 after 210 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K052612: Disposable Powder Free Vinyl Exam Gloves with Vitamin Complex, Nopal and Lanolin Blue Color (2005), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K040108
Methodology: https://510kreport.com/methodology