FDA Facts:
All medical gloves are categorized by the FDA as medical devices and require 510k registrations by the manufacturer, which establishes procedures and tracking systems designed to ensure the integrity of the gloves. The penalties for non-compliance are such that you can be confident that manufacturers and importers are complying with the standards. Note that the FDA utilizes performance standards established by ASTM. For more information on the ASTM, go to www.astm.org.
Now, how do you know if the gloves you are buying are 510k registered as medical gloves and comply with the FDA minimum standards?
Unfortunately there is no standard statement or Icon defined and required by the FDA. However, if the Internet descriptions, literature, tech sheets and/or packaging for a glove use one or more of the following industry terms, you can be confident that the gloves meet or exceed the minimum standards set forth by the FDA for medical applications:
* 510K Registered
* Meets or Exceeds all ASTM Standards
* Recommended for Healthcare, Medical, and or Dental Applications
* Examination or Exam, or Exam Grade
* If you can identify the 510k number for the product you are using or considering, go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm and enter the 510k number to research the product history with the FDA.
You can also be confident your Gloves are not regulated if one of the below conditions and/or statements are listed.
* The absence of the above statements
* Industrial
* For Industrial Use Only
* General Use
* All Purpose
* USDA Accepted