Regulatory Requirements for Medical Gloves: A Workshop Manual

摘要

The manual covers the basic regulatory requirements that all manufacturers and importers must consider when they plan to market medical gloves. Manufacturers and importers must be familiar with the requirements, must be able to determine which ones are pertinent to their individual situation, and must follow the proper sequence in meeting the requirements. The publication is a reference source for information on establishment registration, device listing, labeling, premarket notification (510(k)), and good manufacturing practices. Some of the material herein was presented at an International Latex Conference in Baltimore, Maryland, on November 5-7, 1992. At this Conference, issues related to latex devices were discussed by FDA, industry, and the healthcare community.