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FDA 510(k)

Non-spermicidal Lubricated Male Latex Condom

K-Number: K193578 · 2020-08-20

ApplicantGlobal Protection Corp.
Decision Date2020-08-20
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Non-spermicidal Lubricated Male Latex 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 2020-08-20 under 510(k) number K193578. 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 Non-spermicidal Lubricated Male Latex Condom?

Non-spermicidal Lubricated Male Latex Condom is a medical device that received FDA 510(k) clearance on 2020-08-20. The listed applicant is Global Protection Corp.. The 510(k) number is K193578.

When did Non-spermicidal Lubricated Male Latex Condom receive FDA 510(k) clearance?

Non-spermicidal Lubricated Male Latex Condom received FDA 510(k) clearance on 2020-08-20, under 510(k) number K193578.

Who is the listed applicant for Non-spermicidal Lubricated Male Latex 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 Non-spermicidal Lubricated Male Latex Condom?

The FDA product code for Non-spermicidal Lubricated Male Latex Condom is HIS.

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

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 LubricantK243967ONE Nitrile CondomK240896ONE Nitrile CondomK223214Powder-Free Nitrile Examination GlovesK213087Natural Rubber Latex Ultrasound Transducer Probe Covers

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Related Devices (Code: HIS)

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.

K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.K2435840.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc.

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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