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Remed Male Latex Condom (Double Whooper) Preventor, Lucky Boy and Summit

by Remed Pharma

510(k) K993395

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 · Abbreviated NumberK993395 Date15 Feb 2000ClearedStatusActive

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  • Withdrawn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.

This device is a male condom (FDA classification: Condom, Device Class II), designed as a physical barrier for contraception and the prevention of sexually transmitted diseases. It consists of a natural rubber latex sheath with a ribbed and dotted surface, contoured shape, and a reservoir tip to ensure secure placement and comfort during use.

The condom is intended for over-the-counter use and is supplied as a single-use item. It requires no sterilization or regulatory approval beyond its FDA 510(k) clearance (K993395) under the Abbreviated pathway, classified under regulation number 884.5300. Each unit is packaged individually for hygiene and convenience, with no MRI safety considerations due to its non-metallic composition.

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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 are the key features that make this condom designed for comfort and secure placement during use?

    This condom features a ribbed and dotted surface along with a contoured shape, which enhances grip and sensory experience. The reservoir tip is specifically designed to ensure secure placement and prevent slippage, improving both comfort and effectiveness during use.

  • Is this condom reusable, or is it intended for single-use only?

    The condom is explicitly designed for single-use only, as indicated in the product description. This ensures hygiene and prevents cross-contamination between uses.

  • What materials is this condom made from, and does it require any special handling or sterilization?

    This condom is made from natural rubber latex and does not require sterilization before use. It is individually packaged for hygiene, and since it is single-use, no additional handling or preparation is needed beyond opening the package.

  • Are there different sizes or models available for this condom, and how would I identify them?

    Yes, multiple models are available, as indicated by the extensive list of registration numbers (e.g., 2084177, 3003592318, etc.). These likely correspond to different sizes or variations (e.g., Double Whooper, Lucky Boy, Summit). The packaging or product labeling should specify the exact model and size for each unit.

  • How should this condom be stored to maintain its integrity and effectiveness?

    Since the condom is individually packaged and designed for single-use, it should be stored in a cool, dry place away from direct sunlight or extreme temperatures. Avoid storing it in areas with strong odors, as these could affect its texture or scent. Always check the packaging for expiration dates before use.