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FDA 510(k)

CONDOMS (RUBBER CONTRACEPTIVES)

K-Number: K910284 · 1991-06-04

ApplicantSuretex, Ltd.
Decision Date1991-06-04
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONDOMS (RUBBER CONTRACEPTIVES) is the device name listed in this FDA 510(k) record. The listed applicant is Suretex, Ltd.. It received FDA 510(k) clearance on 1991-06-04 under 510(k) number K910284. 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 CONDOMS (RUBBER CONTRACEPTIVES)?

CONDOMS (RUBBER CONTRACEPTIVES) is a medical device that received FDA 510(k) clearance on 1991-06-04. The listed applicant is Suretex, Ltd.. The 510(k) number is K910284.

When did CONDOMS (RUBBER CONTRACEPTIVES) receive FDA 510(k) clearance?

CONDOMS (RUBBER CONTRACEPTIVES) received FDA 510(k) clearance on 1991-06-04, under 510(k) number K910284.

Who is the listed applicant for CONDOMS (RUBBER CONTRACEPTIVES)?

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 CONDOMS (RUBBER CONTRACEPTIVES)?

The FDA product code for CONDOMS (RUBBER CONTRACEPTIVES) 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 CONDOMK942858LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)

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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