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FDA 510(k)

JIFFI CONDOM (RUBBER) CONTRACEPTIVE

K-Number: K913813 · 1992-06-01

ApplicantSime Health, Ltd.
Decision Date1992-06-01
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

JIFFI CONDOM (RUBBER) CONTRACEPTIVE 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 1992-06-01 under 510(k) number K913813. 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 JIFFI CONDOM (RUBBER) CONTRACEPTIVE?

JIFFI CONDOM (RUBBER) CONTRACEPTIVE is a medical device that received FDA 510(k) clearance on 1992-06-01. The listed applicant is Sime Health, Ltd.. The 510(k) number is K913813.

When did JIFFI CONDOM (RUBBER) CONTRACEPTIVE receive FDA 510(k) clearance?

JIFFI CONDOM (RUBBER) CONTRACEPTIVE received FDA 510(k) clearance on 1992-06-01, under 510(k) number K913813.

Who is the listed applicant for JIFFI CONDOM (RUBBER) CONTRACEPTIVE?

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 JIFFI CONDOM (RUBBER) CONTRACEPTIVE?

The FDA product code for JIFFI CONDOM (RUBBER) CONTRACEPTIVE 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.

K954051SIME POWDERFREE PLUSK954025SIME SURGICAL POWDERFREEK932985AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFIK932982SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K932983COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K932984UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI

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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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