# K100694: Colored Powder Free and Polymer Coated Examination Glove (Blue, Black and Pink) with a Protein Claim of Less Than

- Pathway: 510(k) (Traditional)
- Applicant: Tekmedic (M) Sdn Bhd
- Decided: Jun 25, 2010 after 106 days
- Product code: LYY (Latex Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Dec 22, 2011 · Not classified · Z-0712-2012: The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.

## Indications for use
A colored, powder-free and polymer coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or fingers for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color blend is added to the latex examination glove in the production process to produce the colored glove.

Source page: https://510kreport.com/device/K100694
Methodology: https://510kreport.com/methodology