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FDA 510(k)

EZ-ON CONDOM

K-Number: K001974 · 2001-10-24

ApplicantMayer Laboratories
Decision Date2001-10-24
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EZ-ON 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 2001-10-24 under 510(k) number K001974. 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 EZ-ON CONDOM?

EZ-ON CONDOM is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Mayer Laboratories. The 510(k) number is K001974.

When did EZ-ON CONDOM receive FDA 510(k) clearance?

EZ-ON CONDOM received FDA 510(k) clearance on 2001-10-24, under 510(k) number K001974.

Who is the listed applicant for EZ-ON 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 EZ-ON CONDOM?

The FDA product code for EZ-ON CONDOM is MOL.

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Other records listing Mayer Laboratories as applicant

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.

K252158Sagami Original 002 Polyurethane Male CondomK946374KIMONO MICROTHINK943064KIMONO (CONDOMS)K946376MAXXK925869SHEATHES, STERILE SHEATHESK926049DIGITEX, DIGITEX HYPOALLERGENIC

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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.

K252158Sagami Original 002 Polyurethane Male CondomMayer LaboratoriesK243967ONE 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 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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