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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.

  1. Determine which labeling claim is desired (Low Dermatitis Potential or specific chemical claim)
  2. Conduct required biocompatibility testing according to FDA Guidance for Medical Gloves
  3. For Low Dermatitis Potential claim:
    • Conduct Modified Draize-95 Test on 200 subjects
    • Maintain test data on file
  4. 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
  5. Ensure labeling includes required warnings and complies with prohibited claim restrictions
  6. Maintain detailed documentation of all testing procedures and results
  7. Obtain necessary IRB approvals and informed consent for human testing
  8. 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:
    1. “Low Dermatitis Potential” claim
    2. “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

  • FDA 96-4257: Guidance for Medical Gloves: A Workshop Manual

Original guidance

  • Labeling Claims for Reduced Chemical Sensitivity in Natural Rubber Medical Devices
  • HTML / PDF
  • Issue date: 1999-01-12
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: cbf12f09409fea85e59b918198134b92
This post is licensed under CC BY 4.0 by the author.