# K093496: Non-Sterile, Powder-Free, Pink Latex Examination Gloves with and/or Without Strawberry Scent and with Protein Content

- Pathway: 510(k) (Traditional)
- Applicant: Oon Corp. Resources
- Decided: Feb 3, 2010 after 85 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 NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVE WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN LABELING CLAIM (50 micrograms or less) IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Source page: https://510kreport.com/device/K093496
Methodology: https://510kreport.com/methodology