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FDA 510(k)

MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT

K-Number: K895640 · 1990-01-23

ApplicantArmkel, LLC
Decision Date1990-01-23
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1990-01-23 under 510(k) number K895640. 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 MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT?

MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT is a medical device that received FDA 510(k) clearance on 1990-01-23. The listed applicant is Armkel, LLC. The 510(k) number is K895640.

When did MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT receive FDA 510(k) clearance?

MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT received FDA 510(k) clearance on 1990-01-23, under 510(k) number K895640.

Who is the listed applicant for MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT?

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

What is the FDA product code for MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT?

The FDA product code for MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT is HIS.

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Other records listing Armkel, LLC as applicant

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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.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.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.

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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