# K123757: Powder Free Latex Patient Examination Gloves, with Protein Content Labeling Claim, Natural Color

- Pathway: 510(k) (Traditional)
- Applicant: Assurguard Sdn. Bhd.
- Decided: Feb 1, 2013 after 56 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: 2 generations back to K932521 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112988: Powder Free Latex Patient Exam Glove with Protein Labeling Claim (50 Micrograms Per DM Squared or Less of Water Soluble, Northstar Healthcare Holdings Limited (2011)

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K123757
Methodology: https://510kreport.com/methodology