
Okamoto USA, Inc.
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Male Latex Condom HA is an FDA 510(k)-cleared medical device (K252622) manufactured by Okamoto 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 May 3, 2026. Regulation: 8.

Ansell
SKU MSC846624

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McKesson
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SKU VM-1270031