# K103650: Non-Sterile, Powder-Free, Blue Latex Examination Gloves, Without Bubble Gum or Grape Scent,W/ Protein Content Claim

- Pathway: 510(k) (Traditional)
- Applicant: Oon Corp. Resources
- Decided: Mar 23, 2011 after 99 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 Powder-Free Patient Examination Glove 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/K103650
Methodology: https://510kreport.com/methodology