Compliance Policy Guide: Surgeons' Gloves and Patient Examination Gloves; Defects-Criteria for Direct Reference Seizure

The Food and Drug Administration (FDA) is announcing the availability of Compliance Policy Guide Sec. 335.700, Surgeons' Gloves and Patient Examination Gloves; Defects--Criteria for Direct Reference Seizure (the CPG). The CPG, which was originally issued in 1991, provides guidance to FDA staff on the submission of seizure recommendations for medical gloves that exceed the defect levels in FDA regulations. The CPG has been revised to remove an appendix that became obsolete when the regulations were amended, and to make other minor changes for clarity and consistency with the amended regulation.