FDA Labeling Requirements for Examination & Surgical Gloves
Latex and nitrile examination and surgical gloves must comply with FDA medical device labeling requirements under 21 CFR Part 801.
Liberty Management GroupSince 2009
FDA regulates latex and nitrile examination and surgical gloves as medical devices. All device labels must comply with 21 CFR Part 801 (Medical Device Labeling Regulations).
- Device name and intended use
- Manufacturer name and address
- Lot/batch number or serial number
- Manufacturing date
- Instructions for use (if required)
- UDI — Unique Device Identifier on label and package
- Latex allergy warning (for latex gloves): “CAUTION: This product contains natural rubber latex which may cause allergic reactions”
- Sterility statement (for sterile gloves)
- Glove size and quantity
LMG provides medical device label review services for glove manufacturers to ensure FDA 21 CFR Part 801 compliance before market entry.
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Device Services
- Medical Device Establishment Registration
- Premarket Notification 510(k)
- FDA Registration for Latex Nitrile Gloves
- Tests Required for Examination Surgical Gloves
- Biocompatibility Tests for Examination Surgical Gloves
- Contents of Examination Surgical Gloves
- FDA Registration for Surgical Face Masks
- FDA Premarket Approval PMA
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