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FDA 510(k)

ONE Nitrile Condom

K-Number: K243967 · 2025-04-08

ApplicantGlobal Protection Corp.
Decision Date2025-04-08
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ONE Nitrile Condom is the device name listed in this FDA 510(k) record. The listed applicant is Global Protection Corp.. It received FDA 510(k) clearance on 2025-04-08 under 510(k) number K243967. 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 ONE Nitrile Condom?

ONE Nitrile Condom is a medical device that received FDA 510(k) clearance on 2025-04-08. The listed applicant is Global Protection Corp.. The 510(k) number is K243967.

When did ONE Nitrile Condom receive FDA 510(k) clearance?

ONE Nitrile Condom received FDA 510(k) clearance on 2025-04-08, under 510(k) number K243967.

Who is the listed applicant for ONE Nitrile Condom?

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

What is the FDA product code for ONE Nitrile Condom?

The FDA product code for ONE Nitrile Condom is MOL.

Other records listing Global Protection Corp. 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.

K250142Water-based LubricantK243972Plain Water-based LubricantK240896ONE Nitrile CondomK223214Powder-Free Nitrile Examination GlovesK213087Natural Rubber Latex Ultrasound Transducer Probe CoversK203536Male Latex Condom

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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 LaboratoriesK241617Durex 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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