# K083571: Illusion Powder Free Exam Gloves, Natural Color with Vanilla Scent, Orange Color with Citric Scent and Pink Color

- Pathway: 510(k) (Traditional)
- Applicant: Purna Bina Sdn Bhd
- Decided: Aug 13, 2009 after 253 days
- Product code: LYY (Latex 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 patient 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.

Source page: https://510kreport.com/device/K083571
Methodology: https://510kreport.com/methodology