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FDA 510(k)

TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM

K-Number: K081413 · 2008-10-24

ApplicantDailian Latex Company, Ltd.
Decision Date2008-10-24
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Dailian Latex Company, Ltd.. It received FDA 510(k) clearance on 2008-10-24 under 510(k) number K081413. 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 TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM?

TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM is a medical device that received FDA 510(k) clearance on 2008-10-24. The listed applicant is Dailian Latex Company, Ltd.. The 510(k) number is K081413.

When did TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM receive FDA 510(k) clearance?

TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM received FDA 510(k) clearance on 2008-10-24, under 510(k) number K081413.

Who is the listed applicant for TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM?

The FDA 510(k) record lists Dailian Latex Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM?

The FDA product code for TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM 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

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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