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FDA 510(k)

NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL

K-Number: K002060 · 2000-09-07

ApplicantDongkuk Techco Rubber Industries
Decision Date2000-09-07
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL is the device name listed in this FDA 510(k) record. The listed applicant is Dongkuk Techco Rubber Industries. It received FDA 510(k) clearance on 2000-09-07 under 510(k) number K002060. 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 NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL?

NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL is a medical device that received FDA 510(k) clearance on 2000-09-07. The listed applicant is Dongkuk Techco Rubber Industries. The 510(k) number is K002060.

When did NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL receive FDA 510(k) clearance?

NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL received FDA 510(k) clearance on 2000-09-07, under 510(k) number K002060.

Who is the listed applicant for NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL?

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

What is the FDA product code for NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL?

The FDA product code for NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL 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 Dongkuk Techco Rubber Industries 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.

K864570PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME

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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