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FDA 510(k)

OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS

K-Number: K994118 · 2000-08-14

ApplicantGuilin Latex Factory
Decision Date2000-08-14
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Latex Factory. It received FDA 510(k) clearance on 2000-08-14 under 510(k) number K994118. 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 OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS?

OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS is a medical device that received FDA 510(k) clearance on 2000-08-14. The listed applicant is Guilin Latex Factory. The 510(k) number is K994118.

When did OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS receive FDA 510(k) clearance?

OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS received FDA 510(k) clearance on 2000-08-14, under 510(k) number K994118.

Who is the listed applicant for OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS?

The FDA 510(k) record lists Guilin Latex Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS?

The FDA product code for OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS is HIS.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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