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FDA 510(k)

RUBBER CONDOM (NON-COLORED)

K-Number: K896987 · 1990-06-06

ApplicantHankook Latex Gongup Co., Ltd.
Decision Date1990-06-06
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RUBBER CONDOM (NON-COLORED) is the device name listed in this FDA 510(k) record. The listed applicant is Hankook Latex Gongup Co., Ltd.. It received FDA 510(k) clearance on 1990-06-06 under 510(k) number K896987. 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 RUBBER CONDOM (NON-COLORED)?

RUBBER CONDOM (NON-COLORED) is a medical device that received FDA 510(k) clearance on 1990-06-06. The listed applicant is Hankook Latex Gongup Co., Ltd.. The 510(k) number is K896987.

When did RUBBER CONDOM (NON-COLORED) receive FDA 510(k) clearance?

RUBBER CONDOM (NON-COLORED) received FDA 510(k) clearance on 1990-06-06, under 510(k) number K896987.

Who is the listed applicant for RUBBER CONDOM (NON-COLORED)?

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

What is the FDA product code for RUBBER CONDOM (NON-COLORED)?

The FDA product code for RUBBER CONDOM (NON-COLORED) 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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