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FDA 510(k)

Male Latex Condom HA

K-Number: K252622 · 2026-05-04

ApplicantOkamoto USA, Inc.
Decision Date2026-05-04
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Male Latex Condom HA is a medical device manufactured by Okamoto USA, Inc.. It received FDA 510(k) clearance on 2026-05-04 under approval number K252622. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Male Latex Condom HA?

Male Latex Condom HA is a medical device that received FDA 510(k) clearance on 2026-05-04. It is manufactured by Okamoto USA, Inc.. The 510(k) number is K252622.

When was Male Latex Condom HA approved by the FDA?

Male Latex Condom HA received FDA 510(k) clearance on 2026-05-04, under approval number K252622.

What company makes Male Latex Condom HA?

Male Latex Condom HA is manufactured by Okamoto USA, Inc..

What is the FDA product code for Male Latex Condom HA?

The FDA product code for Male Latex Condom HA is HIS.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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