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FDA 510(k)

Sagami Original 002 Polyurethane Male Condom

K-Number: K252158 · 2026-03-30

ApplicantMayer Laboratories
Decision Date2026-03-30
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sagami Original 002 Polyurethane Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 2026-03-30 under 510(k) 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. The listed applicant is Mayer Laboratories. The 510(k) number is K252158.

When did Sagami Original 002 Polyurethane Male Condom receive FDA 510(k) clearance?

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

Who is the listed applicant for Sagami Original 002 Polyurethane Male Condom?

The FDA 510(k) record lists Mayer Laboratories as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06557499A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.COMPLETED

Related Devices (Code: MOL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243967ONE Nitrile CondomGlobal Protection Corp.K241617Durex Polyisoprene CondomRb Health (Us), LLCK240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.K240896ONE Nitrile CondomGlobal Protection Corp.K232470Polyisoprene Extra Large CondomSuretex LimitedK23190845 Micron Polyisoprene CondomSuretex Limited

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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