# K092492: Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling Claim of 50 Micrograms Per DM2 O

- Pathway: 510(k) (Traditional)
- Applicant: Wear Safe (Malaysia) Sdn. Bhd.
- Decided: Oct 21, 2009 after 69 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; 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K112612: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim (2012), 1 descendant of its own
- K153744: A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) (2016), 0 descendants of its own

## Indications for use
A powder free polymer coated latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K092492
Methodology: https://510kreport.com/methodology