SecureFit Condoms are manufactured in state-of-the-art facilities that adhere strictly to U.S. Food and Drug Administration (FDA) regulations for Class II medical devices under 21 CFR Part 884. Our production processes incorporate Good Manufacturing Practices (GMP) to ensure product sterility, biocompatibility, and performance consistency. Each batch undergoes rigorous electronic burst testing, air inflation integrity checks, and dimensional verification to confirm compliance with FDA 510(k) premarket notification requirements, guaranteeing that every condom meets or exceeds federal safety thresholds for leakage, breakage, and material purity.
Our innovative design is protected by a patent-pending application filed with the United States Patent and Trademark Office (USPTO), under provisional application number [redacted for confidentiality]. This intellectual property safeguards the unique fastening mechanism, which employs a novel combination of elastomeric grips and adhesive polymers to enhance retention without inducing dermal irritation or allergic responses, as validated through ISO 10993 biocompatibility testing.
Furthermore, our manufacturing plant is certified under ISO 13485:2016, the international standard for quality management systems in medical device production. This certification encompasses risk management per ISO 14971, ensuring traceability from raw material sourcing—such as medical-grade polyisoprene or polyurethane—to final packaging. Audits by accredited bodies confirm our adherence to these protocols, minimizing variability in product efficacy and supporting global distribution while prioritizing user safety.
SecureFit Condoms are manufactured in state-of-the-art facilities that adhere strictly to U.S. Food and Drug Administration (FDA) regulations for Class II medical devices under 21 CFR Part 884. Our production processes incorporate Good Manufacturing Practices (GMP) to ensure product sterility, biocompatibility, and performance consistency. Each batch undergoes rigorous electronic burst testing, air inflation integrity checks, and dimensional verification to confirm compliance with FDA 510(k) premarket notification requirements, guaranteeing that every condom meets or exceeds federal safety thresholds for leakage, breakage, and material purity.
Our innovative design is protected by a patent-pending application filed with the United States Patent and Trademark Office (USPTO), under provisional application number [redacted for confidentiality]. This intellectual property safeguards the unique fastening mechanism, which employs a novel combination of elastomeric grips and adhesive polymers to enhance retention without inducing dermal irritation or allergic responses, as validated through ISO 10993 biocompatibility testing.
Furthermore, our manufacturing plant is certified under ISO 13485:2016, the international standard for quality management systems in medical device production. This certification encompasses risk management per ISO 14971, ensuring traceability from raw material sourcing—such as medical-grade polyisoprene or polyurethane—to final packaging. Audits by accredited bodies confirm our adherence to these protocols, minimizing variability in product efficacy and supporting global distribution while prioritizing user safety.
