# K033835: Disposable Powder Free Vinyl Synthetic Examination Glove, White Color

- Pathway: 510(k) (Traditional)
- Applicant: Mdm Enterprise Corp.
- Decided: Jan 22, 2004 after 43 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.
2 later devices descend from it; 2 cite 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. The FDA summary names no predicate by number.

## Most influential descendants
- K081535: Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color (2008), 0 descendants of its own
- K072377: Disposable Powder Free Vinyl Synthetic Exam Glove, White Color (2007), 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 the patient and examiner.

Source page: https://510kreport.com/device/K033835
Methodology: https://510kreport.com/methodology