ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS

ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS is an FDA 510(k)-cleared medical device (K971132) manufactured by G. Premjee (Usa), Inc.. 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 September 2, 1997. Regulation: 8.