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FDA 510(k)

SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)

K-Number: K932982 · 1994-07-07

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

Device Summary

SPERMICIDAL LUBRIC. 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 K932982. 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 SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)?

SPERMICIDAL LUBRIC. 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 K932982.

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

SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI) received FDA 510(k) clearance on 1994-07-07, under 510(k) number K932982.

Who is the listed applicant for SPERMICIDAL LUBRIC. 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 SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)?

The FDA product code for SPERMICIDAL LUBRIC. 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 & JIFFIK932984UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFIK932983COLORED 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.

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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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