FDA 510(k)

Sagami Original 002 Polyurethane Male Condom

K-Number: K252158 · 2026-03-30

Decision Date2026-03-30

Product CodeMOL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Sagami Original 002 Polyurethane Male Condom is a medical device manufactured by Mayer Laboratories. It received FDA 510(k) clearance on 2026-03-30 under approval number K252158. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sagami Original 002 Polyurethane Male Condom?

Sagami Original 002 Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2026-03-30. It is manufactured by Mayer Laboratories. The 510(k) number is K252158.

When was Sagami Original 002 Polyurethane Male Condom approved by the FDA?

Sagami Original 002 Polyurethane Male Condom received FDA 510(k) clearance on 2026-03-30, under approval number K252158.

What company makes Sagami Original 002 Polyurethane Male Condom?

Sagami Original 002 Polyurethane Male Condom is manufactured by Mayer Laboratories.

What is the FDA product code for Sagami Original 002 Polyurethane Male Condom?

The FDA product code for Sagami Original 002 Polyurethane Male Condom is MOL.

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Official Source

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