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FDA 510(k)

SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED

K-Number: K993781 · 2000-02-02

ApplicantP.T. Vonix Latexindo Condom (Rubber) Mfg.
Decision Date2000-02-02
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Vonix Latexindo Condom (Rubber) Mfg.. It received FDA 510(k) clearance on 2000-02-02 under 510(k) number K993781. 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 SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED?

SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED is a medical device that received FDA 510(k) clearance on 2000-02-02. The listed applicant is P.T. Vonix Latexindo Condom (Rubber) Mfg.. The 510(k) number is K993781.

When did SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED receive FDA 510(k) clearance?

SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED received FDA 510(k) clearance on 2000-02-02, under 510(k) number K993781.

Who is the listed applicant for SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED?

The FDA 510(k) record lists P.T. Vonix Latexindo Condom (Rubber) Mfg. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED?

The FDA product code for SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED 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 P.T. Vonix Latexindo Condom (Rubber) Mfg. 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.

K993779SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATEDK993782SIMPLEX CONDOMS, LATEX CONDOMS-WITH 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

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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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