Labeling Claims for Reduced Chemical Sensitivity in Natural Rubber Medical Devices
This guidance provides recommendations for manufacturers and FDA personnel regarding 510(k) submissions for natural rubber (NR) medical devices with labeling claims for: - Reduced potential for sensitizing users to rubber chemical additives - Reduced potential for causing reaction in individuals sensitized to rubber chemical additives The guidance focuses specifically on Type IV allergy (delayed hypersensitivity) to residual chemicals in NR products, not Type I allergy (immediate hypersensitivity to proteins) or irritation reactions.
Recommended Actions
- Determine which labeling claim is desired (Low Dermatitis Potential or specific chemical claim)
- Conduct required biocompatibility testing according to FDA Guidance for Medical Gloves
- For Low Dermatitis Potential claim:
- Conduct Modified Draize-95 Test on 200 subjects
- Maintain test data on file
- For specific chemical claims:
- Complete Modified Draize-95 Test
- Conduct additional patch testing on 25 sensitized individuals
- Submit new 510(k) with complete test data
- Ensure labeling includes required warnings and complies with prohibited claim restrictions
- Maintain detailed documentation of all testing procedures and results
- Obtain necessary IRB approvals and informed consent for human testing
- Follow proper statistical analysis and reporting requirements for test results
Key Considerations
Clinical testing
- Modified Draize-95 Test required on minimum 200 non-sensitized subjects
- Patch test required on minimum 25 pre-diagnosed allergic individuals for specific chemical claims
- Specific inclusion/exclusion criteria for test subjects provided
- Detailed scoring criteria and evaluation procedures defined
Non-clinical testing
- Basic biocompatibility testing required including skin irritation and dermal sensitization studies in animals
Labelling
- “Hypoallergenic” claim prohibited
- Two specific claims allowed with supporting data:
- “Low Dermatitis Potential” claim
- “Low Thiuram/Carbamate/Thiazole” claim
- Warning statements required regarding natural rubber protein allergy
Biocompatibility
- Basic biocompatibility testing required per FDA manual “Guidance for Medical Gloves”
- Focus on skin sensitization and irritation testing
Safety
- Studies considered “non-significant risk” under IDE regulations
- IRB approval and informed consent required
- Compliance with Helsinki Declaration for foreign studies
Other considerations
- Statistical requirements defined for test sample sizes
- Detailed documentation and reporting requirements
- Specific procedures for handling adverse reactions during testing
Relevant Guidances
- Medical Gloves - Premarket Notification, Quality System, Labeling and Compliance Requirements
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- FDA 96-4257: Guidance for Medical Gloves: A Workshop Manual
Original guidance
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