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)

EXTRAWEAR, GENTLEMEN'S CHOICE

K-Number: K972428 · 1997-08-25

ApplicantCustom Services Intl., Inc.
Decision Date1997-08-25
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EXTRAWEAR, GENTLEMEN'S CHOICE is the device name listed in this FDA 510(k) record. The listed applicant is Custom Services Intl., Inc.. It received FDA 510(k) clearance on 1997-08-25 under 510(k) number K972428. 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 EXTRAWEAR, GENTLEMEN'S CHOICE?

EXTRAWEAR, GENTLEMEN'S CHOICE is a medical device that received FDA 510(k) clearance on 1997-08-25. The listed applicant is Custom Services Intl., Inc.. The 510(k) number is K972428.

When did EXTRAWEAR, GENTLEMEN'S CHOICE receive FDA 510(k) clearance?

EXTRAWEAR, GENTLEMEN'S CHOICE received FDA 510(k) clearance on 1997-08-25, under 510(k) number K972428.

Who is the listed applicant for EXTRAWEAR, GENTLEMEN'S CHOICE?

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

What is the FDA product code for EXTRAWEAR, GENTLEMEN'S CHOICE?

The FDA product code for EXTRAWEAR, GENTLEMEN'S CHOICE 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 Custom Services Intl., 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.

K972429INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9K972430EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9K972427INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINKK970791INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTYK970767CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTHK963321OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN

View all 9 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.

↑