The proposed regulation and draft manual represent significant changes in the requirements for all medical gloves. You can read about these issues on the FDA web site at: 

• Proposed medical glove rule: http://www.fda.gov/ohrms/dockets/98fr/070399a.txt 
• Draft glove manual: http://www.fda.gov/cdrh/manual/glovmanl.pdf (over 300 pages in PDF format) 
• Notice of extension of comment period: http://www.fda.gov/ohrms/dockets/98fr/102899d.txt 

Basically, the proposed rule classifies medical gloves as Class II medical devices subject to special controls, including expiration dating and labeling requirements.

Gloves will be classified into four categories: powdered surgeon’s, powder-free surgeon’s, powdered examination and powder-free examination. In addition to the requirement that gloves bear an expiration date, gloves that contain natural rubber latex and/or powder will be required to bear new caution statements.