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FDA 510(k)

THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION

K-Number: K890407 · 1989-05-16

ApplicantCircle Rubber Corp.
Decision Date1989-05-16
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION is the device name listed in this FDA 510(k) record. The listed applicant is Circle Rubber Corp.. It received FDA 510(k) clearance on 1989-05-16 under 510(k) number K890407. 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 THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION?

THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION is a medical device that received FDA 510(k) clearance on 1989-05-16. The listed applicant is Circle Rubber Corp.. The 510(k) number is K890407.

When did THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION receive FDA 510(k) clearance?

THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION received FDA 510(k) clearance on 1989-05-16, under 510(k) number K890407.

Who is the listed applicant for THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION?

The FDA 510(k) record lists Circle Rubber Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION?

The FDA product code for THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Circle Rubber Corp. 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.

K883467THE SAXON SPERMICIDAL CONDOMK872736PROPHYLACTIC (CONDOM)K842502WRINKLE CHAPEAU BLACKYK813172CONDOM-MULTIPAL STYLES

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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