Led by Andre Butler, CQA, CCRP — 28+ years, 15+ FDA 510(k) clearances, 11 years on a Class III PMA program. Meet the team →
21 CFR 884.5300 · Class II Medical Device
Male condoms are Class II medical devices under 21 CFR 884.5300, cleared through the Traditional 510(k) pathway. Natural rubber latex condoms fall under product code HIS; synthetic condoms — polyurethane, polyisoprene, and other non-latex materials — fall under product code MOL. ADB Consulting & CRO Inc. provides end-to-end FDA market access for condom and contraceptive device manufacturers, from regulatory strategy and predicate selection through eSTAR submission, clearance, and market entry.
Book a Free Pathway CallTesting & Evidence
Scope of Work
Classification, product code, and predicate/substantial-equivalence strategy.
Pre-Submission (Q-Sub) preparation and FDA meeting representation.
Test program management with accredited partner laboratories.
510(k) authoring and full eSTAR preparation, filing, and FDA AI response support.
FDA Small Business Determination applications for reduced user fees.
U.S. Agent, establishment registration, device listing, and UDI/GUDID.
QMSR (21 CFR Part 820) gap assessments and quality agreements for foreign manufacturing sites.
Led by Andre Butler, CQA, CCRP — 28+ years, 15+ FDA 510(k) clearances, 11 years on a Class III PMA program. Meet the team →
Bringing a Condom or Contraceptive Device to the U.S. Market?
Talk through your device and predicate strategy first — we’ll help you find the right starting point, no obligation.