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FDA 510(k)

COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)

K-Number: K932983 · 1994-07-07

ApplicantSime Health, Ltd.
Decision Date1994-07-07
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) is the device name listed in this FDA 510(k) record. The listed applicant is Sime Health, Ltd.. It received FDA 510(k) clearance on 1994-07-07 under 510(k) number K932983. 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 COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)?

COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) is a medical device that received FDA 510(k) clearance on 1994-07-07. The listed applicant is Sime Health, Ltd.. The 510(k) number is K932983.

When did COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) receive FDA 510(k) clearance?

COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) received FDA 510(k) clearance on 1994-07-07, under 510(k) number K932983.

Who is the listed applicant for COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)?

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

What is the FDA product code for COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)?

The FDA product code for COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) is HIS.

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Other records listing Sime Health, 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.

K954025SIME SURGICAL POWDERFREEK954051SIME POWDERFREE PLUSK932985AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFIK932982SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K932984UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFIK940797SIME SURGICAL LATEX GLOVE

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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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