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