LYZ

799 FDA 510(k) clearances · Product code

FDA profile

Official device name

Vinyl Patient Examination Glove

Device class

Class I (low risk)

Regulation

21 CFR 880.6250

Medical specialty

General Hospital

Flags

Third-party review eligible

FDA definition

A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Adverse events (MAUDE)

2006: 2 · 2007: 4 · 2011: 5 · 2012: 5 · 2016: 11 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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