# K022659: Illusion Powder Free-Ploymer Coated Color Scented NR Latex Examination Gloves (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Purna Bina Sdn Bhd
- Decided: Sep 25, 2002 after 47 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. The FDA summary names no predicate by number.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. Suitable for use in medical examination, diagnostic and therapeutic procedures, as well as in the dentistry field.

Source page: https://510kreport.com/device/K022659
Methodology: https://510kreport.com/methodology