Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SKINLESS SKIN-HARMONY CONDOMS

K-Number: K872664 · 1987-11-05

ApplicantOkamoto USA, Inc.
Decision Date1987-11-05
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SKINLESS SKIN-HARMONY CONDOMS is the device name listed in this FDA 510(k) record. The listed applicant is Okamoto USA, Inc.. It received FDA 510(k) clearance on 1987-11-05 under 510(k) number K872664. 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 SKINLESS SKIN-HARMONY CONDOMS?

SKINLESS SKIN-HARMONY CONDOMS is a medical device that received FDA 510(k) clearance on 1987-11-05. The listed applicant is Okamoto USA, Inc.. The 510(k) number is K872664.

When did SKINLESS SKIN-HARMONY CONDOMS receive FDA 510(k) clearance?

SKINLESS SKIN-HARMONY CONDOMS received FDA 510(k) clearance on 1987-11-05, under 510(k) number K872664.

Who is the listed applicant for SKINLESS SKIN-HARMONY CONDOMS?

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

What is the FDA product code for SKINLESS SKIN-HARMONY CONDOMS?

The FDA product code for SKINLESS SKIN-HARMONY CONDOMS 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 Okamoto USA, Inc. 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.

K252622Male Latex Condom HAK2435840.04 ZERO ZERO FOUR Male Latex CondomK203541Okamoto 002 Lubricated Polyurethane Male CondomK192669Extremely Thin 003, ZERO ZERO THREEK090259OKAMOTO ULTRA THINK952393OKAMOTO CONDOM

View all 13 devices →

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.

↑