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FDA 510(k)

LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)

K-Number: K942858 · 1995-05-18

ApplicantSuretex, Ltd.
Decision Date1995-05-18
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) is the device name listed in this FDA 510(k) record. The listed applicant is Suretex, Ltd.. It received FDA 510(k) clearance on 1995-05-18 under 510(k) number K942858. 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 LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)?

LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) is a medical device that received FDA 510(k) clearance on 1995-05-18. The listed applicant is Suretex, Ltd.. The 510(k) number is K942858.

When did LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) receive FDA 510(k) clearance?

LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) received FDA 510(k) clearance on 1995-05-18, under 510(k) number K942858.

Who is the listed applicant for LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)?

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

What is the FDA product code for LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)?

The FDA product code for LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) is HIS.

Related Clinical Trials

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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Other records listing Suretex, 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.

K030176LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANTK010371LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANTK941258LATEX CONDOMK910284CONDOMS (RUBBER CONTRACEPTIVES)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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