US FDA Medical Device Labeling Requirements – Surgical Face Masks
US FDA defines a label as a "display of written, printed, or graphic matter upon the immediate container of any article.” The FDA regulates surgical face masks as medical devices and needs 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, but 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 Assist surgical mask 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 Clearances are public information; you can verify clearance status at the FDA site. Below are examples of surgical masks 510k clearance.