Male Latex Condom HA— 510(k) K252622

Substantially Equivalent

Okamoto USA, Inc.

FDA 510(k) clearance K252622 for Male Latex Condom HA, Substantially Equivalent on 2026-05-04. Applicant: Okamoto USA, Inc..

Clearance details

Applicant: Okamoto USA, Inc.
Product code: Code HIS
Advisory panel: Obstetrics/Gynecology
Date received: 2025-08-19
Decision date: 2026-05-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sandusky, OH, US

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