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FDA 510(k)

MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)

K-Number: K990925 · 1999-06-17

ApplicantHardcover Products, Inc.
Decision Date1999-06-17
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Hardcover Products, Inc.. It received FDA 510(k) clearance on 1999-06-17 under 510(k) number K990925. 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 MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)?

MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) is a medical device that received FDA 510(k) clearance on 1999-06-17. The listed applicant is Hardcover Products, Inc.. The 510(k) number is K990925.

When did MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) receive FDA 510(k) clearance?

MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) received FDA 510(k) clearance on 1999-06-17, under 510(k) number K990925.

Who is the listed applicant for MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)?

The FDA 510(k) record lists Hardcover Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)?

The FDA product code for MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) 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 Hardcover Products, Inc. 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.

K991047HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

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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