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FDA 510(k)

BLACK COLOURED CONDOM

K-Number: K132597 · 2013-11-25

ApplicantKarex Industries Sdn. Bhd.
Decision Date2013-11-25
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BLACK COLOURED CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Karex Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2013-11-25 under 510(k) number K132597. 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 BLACK COLOURED CONDOM?

BLACK COLOURED CONDOM is a medical device that received FDA 510(k) clearance on 2013-11-25. The listed applicant is Karex Industries Sdn. Bhd.. The 510(k) number is K132597.

When did BLACK COLOURED CONDOM receive FDA 510(k) clearance?

BLACK COLOURED CONDOM received FDA 510(k) clearance on 2013-11-25, under 510(k) number K132597.

Who is the listed applicant for BLACK COLOURED CONDOM?

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

What is the FDA product code for BLACK COLOURED CONDOM?

The FDA product code for BLACK COLOURED 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 Karex Industries 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.

K223519Carex Hybrid Personal LubricantK113056ORANGE COLORED CONDOMS ORANGE SCENTK113061LARGE/EXTRA LAGRE CONDOMK081886KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATEDK070830MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)

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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