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Billy Boy Male Latex Condom

by Sheila Pickering PHD

510(k) K103119

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103119 Date24 Feb 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Billy Boy Male Latex Condom is a natural rubber latex sheath designed to cover the penis, featuring a reservoir tip and available in cylindrical or contoured shapes. It is intended for over-the-counter use by individuals for contraception and STI prevention.

The device is lubricated with silicone oil and may include Nivesse aroma. It is supplied as a single-use product and is regulated under FDA 510(k) clearance K103119, with device class II and product code HIS.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Billy Boy Male Latex Condom?

    The Billy Boy Male Latex Condom is designed for over-the-counter use as a contraceptive and to help prevent sexually transmitted infections. It is a natural rubber latex sheath that covers the penis.

  • How is the Billy Boy Male Latex Condom supplied?

    The condom is supplied as a single-use product. It is lubricated with silicone oil and may include Nivesse aroma. It is available in cylindrical or contoured shapes with a reservoir tip.

  • What is the regulatory status of the Billy Boy Male Latex Condom?

    The device is regulated under FDA 510(k) clearance K103119, with device class II and product code HIS. It was determined to be substantially equivalent.

  • Is the Billy Boy Male Latex Condom reusable?

    No, the Billy Boy Male Latex Condom is supplied as a single-use product and should not be reused for safety and effectiveness reasons.