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FDA 510(k)

LATEX CONDOM

K-Number: K994095 · 2000-01-18

ApplicantThai Nippon Rubber Industry Co., Ltd.
Decision Date2000-01-18
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Thai Nippon Rubber Industry Co., Ltd.. It received FDA 510(k) clearance on 2000-01-18 under 510(k) number K994095. 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 LATEX CONDOM?

LATEX CONDOM is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Thai Nippon Rubber Industry Co., Ltd.. The 510(k) number is K994095.

When did LATEX CONDOM receive FDA 510(k) clearance?

LATEX CONDOM received FDA 510(k) clearance on 2000-01-18, under 510(k) number K994095.

Who is the listed applicant for LATEX CONDOM?

The FDA 510(k) record lists Thai Nippon Rubber Industry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX CONDOM?

The FDA product code for 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 Thai Nippon Rubber Industry Co., Ltd. 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.

K081265THAI NIPPON MALE LATEX CONDOMK032909THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOMK011253FLAVORED MALE LATEX CONDOMK001978'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

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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