Sagami Original 002 Polyurethane Male Condom

Sagami Original 002 Polyurethane Male Condom is an FDA 510(k)-cleared medical device (K252158) manufactured by Mayer Laboratories. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2026. Regulation: 8.