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FDA 510(k)

UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI

K-Number: K932984 · 1994-07-07

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

Device Summary

UNLUBRICATED CONDOM, 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 K932984. 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 UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI?

UNLUBRICATED CONDOM, 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 K932984.

When did UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI receive FDA 510(k) clearance?

UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI received FDA 510(k) clearance on 1994-07-07, under 510(k) number K932984.

Who is the listed applicant for UNLUBRICATED CONDOM, 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 UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI?

The FDA product code for UNLUBRICATED CONDOM, 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)K932983COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K940797SIME 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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