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)
- Vinyl
- Nitrile
- Polyurethane
Surgeon’s gloves should be sterile when offered for sale to end users, such as hospitals, clinics, and surgeons.
FDA reviews these devices to ensure that performance criteria such as leak resistance, tear resistance and biocompatibility are met.
Manufacturers are required to identify on the package labeling, the materials used to make the gloves.
Medical gloves are class I reserved devices and are subject to general controls of the Federal Food, Drug, and Cosmetic Act, which include:
▪ Establishment Registration
▪ Device Listing (CFR 21 807)
▪ Premarket Notification 510(k)
▪ Labeling requirements (21 CFR 801) and (21 CFR 801.437 for products containing natural latex)
▪ Quality System (21 CFR 820)
▪ Medical Device Reporting (MDR) of adverse events associated with a medical device
▪ Foreign firms must name a U.S. Agent (21 CFR 807.40).
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.
