US FDA Medical Device Labeling Requirements – Sugical Face Masks

US FDA define label as "display of written, printed, or graphic matter upon the immediate container of any article". FDA regulate surgical face mask as a medical device and need to comply with FDA labeling requirements for surgical face masks. The basic FDA labeling requirements for surgical face mask 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
  • Expiration Date
  • Lot Number
  • Country of Origin

LMG Provide assistance to surgical masks manufacturers in FDA registration, 510k clearance, device listing and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

  • Prepare 510k notification
  • Submission of 510k notification
  • FDA Agent service for 510k submission
  • Guidance in test requirements
  • Register your medical device establishment with FDA
  • List your surgical mask with FDA.

FDA 510K Clearance are public information, you can verify clearance status at FDA site. Below are examples of surgical masks 510k clearance.

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