# K062917: Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50

- Pathway: 510(k) (Traditional)
- Applicant: Wear Safe Malaysia Sdn. Bhd.
- Decided: Nov 2, 2006 after 35 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.
2 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123026: Textured, Blue, Latex, Powder Free Examination Glvoes, with Protein Labeling Claim (50UG/DM or Less of Water Soluble Pro (2012), 0 descendants of its own
- K120692: Latex Examination Gloves (Powder Free) (2012), 0 descendants of its own

## Indications for use
A 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. A 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/K062917
Methodology: https://510kreport.com/methodology