# K051345: Colored Powder Free and Polymer Coated Patient Examination Glove (Pink, Blue, Green and Violet)

- Pathway: 510(k) (Traditional)
- Applicant: Glovco (M) Sdn. Bhd.
- Decided: Jun 23, 2005 after 31 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 colored, powder free and polymer coated patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. The colors pink, blue, green and violet are added respectively to the latex in the production process for the intended colored glove.

Source page: https://510kreport.com/device/K051345
Methodology: https://510kreport.com/methodology