Guidance for Industry and Food and Drug Administration Staff; Premarket Approval Applications for Absorbable Powder for Lubricating a Surgeon's Glove; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon's Glove." This guidance describes the information FDA recommends that you provide in a PMA for absorbable powder for lubricating a surgeon's glove.