Male Latex Condoms - Abbreviated 510k Submissions Using Consensus Standards
This guidance outlines the requirements for submitting a 510(k) premarket notification for male latex condoms using consensus standards for abbreviated submissions. It specifically applies to natural rubber latex condoms classified as Class II devices under 21 CFR §884.5300 and §884.5310 (Condom with spermicidal lubricant).
What You Need to Know? 👇
What are the key consensus standards required for male latex condom 510(k) submissions?
Male latex condoms must conform to ASTM D3492 (Standard Specification for Rubber Contraceptives) and ISO 10993 (Biological Evaluation of Medical Devices). These standards cover physical specifications, safety testing, and biocompatibility requirements for abbreviated 510(k) submissions.
How does the abbreviated 510(k) pathway differ from traditional submissions for condoms?
The abbreviated 510(k) pathway allows manufacturers to declare conformance with recognized consensus standards instead of submitting detailed test data. This streamlines the review process while maintaining safety and effectiveness requirements through standardized testing protocols.
What specific labeling requirements must be included on latex condom packaging?
Latex condoms must include contraceptive effectiveness statements, HIV/STD risk reduction claims, natural rubber latex allergy warnings in bold print, expiration dates, and specific precautions against oil-based lubricants that can damage the condom material.
What biocompatibility testing is required for male latex condoms under ISO 10993?
Required testing includes cytotoxicity (ISO 10993-5), irritation and sensitization (ISO 10993-10), and systemic toxicity (ISO 10993-11) evaluations. These tests ensure the condom materials don’t cause harmful biological responses during intended use.
Can manufacturers use alternative approaches instead of consensus standards for condom submissions?
Yes, manufacturers may use alternative approaches if they satisfy applicable statutory and regulatory requirements. However, consensus standards provide a streamlined pathway and reduce the need for extensive data review by FDA.
What predicate device information is required for substantial equivalence determination?
Manufacturers must identify a legally marketed predicate device with the same intended use and technological characteristics, including the brand name, company, and 510(k) number. Any differences must be justified as not affecting safety or effectiveness.
What You Need to Do 👇
Recommended Actions
- Prepare complete documentation showing conformance to ASTM D3492 requirements
- Conduct and document all required ISO 10993 biocompatibility testing
- Develop comprehensive labeling that includes all required statements and warnings
- Prepare detailed product specifications and latex formulation documentation
- Submit declaration of conformity to recognized consensus standards
- Include complete color additive information if applicable
- Provide clear substantial equivalence comparison to predicate device
- Ensure expiration dating and latex warning requirements are met
- Include all required precautions and directions for use in labeling
- Submit complete 510(k) summary or statement as required
Key Considerations
Non-clinical testing
- Must conform to ASTM D3492 standard specifications including:
- Minimum length of 160mm
- Maximum width of 54mm
- Minimum thickness of 0.03mm
- Air burst test pressure and volume requirements
- Leakage AQL requirements
- Package integrity AQL requirements
Biocompatibility
- Must comply with ISO 10993 requirements for:
- Cytotoxicity (ISO 10993-5)
- Irritation and sensitization (ISO 10993-10)
- Systemic toxicity (ISO 10993-11)
- Sample preparation (ISO 10993-12)
Labeling
- Must include statement of identity and intended use
- Must include contraceptive effectiveness table
- Must include specific precautions and directions for use
- Must include expiration date
- Must include latex warning statement
- For spermicidal lubricant condoms, must include specific cautionary statement
Safety
- Must be manufactured from good quality natural rubber latex
- Must not release toxic, sensitizing, or harmful substances
- Must include appropriate storage conditions
Other considerations
- Must provide complete latex formulation details
- Must provide product specifications and dimensions
- Must provide details of any colorants used with appropriate FDA citations
Relevant Guidances 🔗
- Testing and Labeling Requirements for Non-Latex Male Condoms
- Import Surveillance and Detention Process for Condoms Failing Water Leak Testing Requirements
- Regulatory Requirements for Condom-Like Products and Novelty Condoms
Related references and norms 📂
- ASTM D3492: Standard Specification for Rubber Contraceptives (Male Condoms)
- ISO 10993: Biological Evaluation of Medical Devices
- ASTM D1076-97: Standard Specification for Rubber-Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex