Device Dossier

Polyisoprene surgical glove, non-powdered

Device Dossier for Polyisoprene surgical glove, non-powdered (Polyisoprene surgical glove, non-powdered, Class IIa, sponsor The Glove Company). ARTG…

Intended purpose

It is intended to be used once in an invasive procedure involving a single patient and permanently discarded after use. These gloves are worn on the hands of healthcare personnel to provide barrier protection from cross-contamination between patients and healthcare personnel. The healthcare personnel includes surgeons and operation theatre staff. This device is not a measuring device, not used for screening, monitoring, diagnosing, prognosing, prediction or companion diagnostic devices. This medical device is not intended to identify a disorder or define and differentiate it. This medical device is not automated, qualitative or quantitative device.

TGA Public Summary