FDA Labeling Requirements for Surgical Face Masks
Surgical face masks must comply with FDA medical device labeling requirements under 21 CFR Part 801 and ASTM F2100 performance levels.
Liberty Management GroupSince 2009
Surgical face masks are Class II medical devices. FDA labeling requirements under 21 CFR Part 801 apply. Required label elements include:
- Device name: “Surgical Mask” or “Surgical Face Mask”
- Manufacturer name and address
- Lot/batch number
- Quantity per package
- ASTM F2100 performance level (Level 1, 2, or 3)
- Instructions for use and disposal
- Sterility statement (for sterile masks)
- UDI — Unique Device Identifier
LMG provides medical device label review for surgical mask manufacturers to ensure 21 CFR Part 801 compliance before market entry.
Need FDA Consulting?
Contact Liberty Management Group for expert FDA regulatory consulting.
Contact LMGRelated Pages
Device Services
Supporting Articles