# K112988: Powder Free Latex Patient Exam Glove with Protein Labeling Claim (50 Micrograms Per DM Squared or Less of Water Soluble

- Pathway: 510(k) (Traditional)
- Applicant: Northstar Healthcare Holdings Limited
- Decided: Nov 9, 2011 after 34 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 K932521 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932521: Powderfree Latex Examination Gloves, Top Glove Sdn. Bhd. (1994) Summary page 1.

## Most influential descendants
- K123757: Powder Free Latex Patient Examination Gloves, with Protein Content Labeling Claim, Natural Color (2013), 0 descendants of its own

## Indications for use
The 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/K112988
Methodology: https://510kreport.com/methodology