# K061551: Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 UG or Less)

- Pathway: 510(k) (Special)
- Applicant: Medipure Corporation (M) Sdn. Bhd.
- Decided: Aug 24, 2006 after 80 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
Longest line of descent: 1 generation back to K924356 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924356: Latex Patient Examination Gloves, Medi Pure Corp. (1994) Summary page 1.

## Indications for use
The Powder Free Latex 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 hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K061551
Methodology: https://510kreport.com/methodology