# K041004: Illusion Powder Free-Polymer Coated Color Scented NR Latex Examination Gloves (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Purna Bina Sdn Bhd
- Decided: Jul 2, 2004 after 74 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 patient examination glove is a disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination, diagnostic and therapeutic procedures, as well as in the dentistry field.

Source page: https://510kreport.com/device/K041004
Methodology: https://510kreport.com/methodology