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Pleasure Plus Condom

by Medimix Products, Inc.

510(k) K902772

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 NumberK902772 Date14 Aug 1991ClearedStatusActive

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  • Withdrawn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)

Full name
Pleasure Plus
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.

The Pleasure Plus Condom is a barrier contraceptive device designed to prevent pregnancy and reduce the risk of sexually transmitted infections during sexual intercourse. Classified as a condom under the FDA’s nomenclature, it is intended for single-use protection during vaginal, anal, or oral intercourse.

Supplied as a sterile, latex condom, the Pleasure Plus is intended for individual use and must be inspected for defects prior to application. It is regulated under FDA 510(k) clearance (K902772) and falls under the classification of Class II medical devices (HIS product code). No MRI safety information is provided, and storage conditions are not specified in the regulatory data.

Other devices from Medimix Products, Inc.

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 types of sexual activity is the Pleasure Plus Condom designed to protect against pregnancy and STIs?

    The Pleasure Plus Condom is specifically designed as a barrier contraceptive to prevent pregnancy and reduce the risk of sexually transmitted infections during vaginal, anal, or oral intercourse. Its FDA classification as a condom confirms its use for these purposes.

  • Is the Pleasure Plus Condom reusable, or is it meant for single-use only?

    The Pleasure Plus Condom is explicitly intended for single-use protection. It must be inspected for defects prior to application and should not be reused, as this could compromise its effectiveness and safety.

  • What material is the Pleasure Plus Condom made from, and is it sterile?

    The Pleasure Plus Condom is supplied as a sterile, latex condom. Sterility is a key feature to ensure safety and prevent contamination during use.

  • What regulatory pathway was followed for FDA clearance of the Pleasure Plus Condom?

    The Pleasure Plus Condom received FDA clearance through a 510(k) submission (K902772) under the Traditional 510(k) Review pathway. It was determined to be substantially equivalent to a legally marketed predicate device and falls under the Obstetrics/Gynecology advisory committee’s purview. The product is classified as a Class II medical device under the HIS product code.

  • Are there any specific storage instructions provided for the Pleasure Plus Condom?

    The regulatory data for the Pleasure Plus Condom does not specify storage conditions. However, as a sterile latex product, it should generally be stored in a cool, dry place away from direct sunlight and extreme temperatures to maintain its integrity.