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FDA 510(k)

56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM

K-Number: K012964 · 2001-11-09

ApplicantInnolatex Sdn. Bhd
Decision Date2001-11-09
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Innolatex Sdn. Bhd. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K012964. 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 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM?

56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Innolatex Sdn. Bhd. The 510(k) number is K012964.

When did 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM receive FDA 510(k) clearance?

56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM received FDA 510(k) clearance on 2001-11-09, under 510(k) number K012964.

Who is the listed applicant for 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM?

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

What is the FDA product code for 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM?

The FDA product code for 56MM CONDOM,MALE NATURAL RUBBER 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.

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Other records listing Innolatex Sdn. Bhd 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.

K053367MALE NATURAL RUBBER LATEX CONDOMK041837INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTEDK012665ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANTK012664ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANTK012962DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOMK010919MALE NATURAL RUBBER LATEX CONDOM

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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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