Medical gloves are used by health care personnel to prevent the spread of infection or illness.
Examination gloves, surgical gloves and chemotherapy gloves are made from the following materials:
- Natural rubber latex
- Polyvinyl chloride (PVC)
Surgeon’s gloves should be sterile when offered for sale to end users, such as hospitals, clinics, and surgeons.
A medical device kit may include medical gloves.
Kit manufacturers and assemblers should
assure that gloves in their kits are cleared for marketing and that the gloves can meet the
appropriate FDA and ASTM (American Society for Testing and Materials) standards:
- ASTM D3577
- ASTM D3578
- ASTM D5250
- ASTM D6319
- equivalent test method after the kit is sterilized.
On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed.
The agency now recommends that health care facilities and providers do not purchase, or use imported medical gloves from companies included on Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon’s and Patient Examination Gloves.