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Extrawear, Gentlemen's Choice

by Custom Services Intl., Inc. 510(k)

Active United States

510(k) K972428

Overview

This device is a condom, classified under product code HIS and regulation number 884.5300, intended for use as a barrier contraceptive and disease prevention method. It is a male external condom designed to reduce the risk of pregnancy and sexually transmitted infections during sexual intercourse.

The device is supplied as a single-use, non-sterile product and is cleared for marketing under FDA 510(k) clearance K972428, issued on August 25, 1997. It is manufactured by Custom Services Intl., Inc. in Las Vegas, Nevada, and is subject to special controls as a Class II medical device. No information regarding MRI safety, sizes, or storage conditions is provided in the data.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972428 Date25 Aug 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is EXTRAWEAR, GENTLEMEN'S CHOICE intended for?

    EXTRAWEAR, GENTLEMEN'S CHOICE is intended for use as a barrier contraceptive and disease prevention method during sexual intercourse to reduce the risk of pregnancy and sexually transmitted infections.

  • How is EXTRAWEAR, GENTLEMEN'S CHOICE supplied and is it reusable?

    EXTRAWEAR, GENTLEMEN'S CHOICE is supplied as a single-use, non-sterile product and is not intended for reuse; it must be discarded after each use to maintain effectiveness and safety.

  • What regulatory clearance does EXTRAWEAR, GENTLEMEN'S CHOICE have?

    EXTRAWEAR, GENTLEMEN'S CHOICE is cleared for marketing under FDA 510(k) clearance K972428, issued on August 25, 1997, and is classified as a Class II medical device under product code HIS and regulation number 884.5300.