US FDA Medical Device Labeling Requirements - Gloves

US FDA define label as "display of written, printed, or graphic matter upon the immediate container of any article". There are specific labeling requirements for examination and surgical gloves (nitrile and latex). The basic FDA requirements for nitrile and latex glove is listed below, this is not a complete list of requirements, the requirements may change.

  • Name and Place of Business
  • Statement of Identity
  • Comply with Language requirements
  • Net Quantity of Contents statement
  • Adequate Directions for Use
  • Caution statement for Natural Rubber Latex
  • Caution statement for Protein Label claim
  • Expiration Date
  • Identify the Standards complying with
  • Lot Number
  • Country of Origin

If you need assistance with a medical device label review, please contact us, our fees for medical device label review is USD 649/Device. After completing label review, we will issue a FDA compliance certificate for your records.

Biocompatibility tests required for examination and surgical gloves

Physical tests required for examination and surgical gloves

FDA Classification for examination and surgical gloves

Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification

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