Medical Devices; Draft Guidance for Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Guidance for Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves." Many foreign manufacturers and shippers of surgeons' and/or patient examination gloves have consistently failed to provide surgeons' and/or patient examination gloves of adequate quality for distribution in the United States, which presents a potential serious hazard to health for users and patients. The draft guidance is intended to help industry understand our policy to monitor continuously recidivist firms under our import program. This policy is neither final nor is it in effect at this time.