Skip to content

Rubber Condom (Non-Colored)

by Hankook Latex Gongup Co., Ltd.

510(k) K896987

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 NumberK896987 Date6 Jun 1990ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

A rubber condom (non-colored) is a barrier device intended for use during sexual intercourse to reduce the risk of pregnancy and sexually transmitted infections. It is made from natural rubber latex and is designed to be worn on the penis.

This device is supplied non-sterile and intended for single-use only. It is regulated as a Class II medical device under FDA 510(k) clearance (K896987) with product code HIS and regulation number 884.5300, and is authorized for distribution in the United States.

Other devices from Hankook Latex Gongup Co., Ltd.

  • Banana Gold

    Class II

Questions

AI-generated answers, 21 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 rubber condom (non-colored) intended for?

    It is a barrier device intended for use during sexual intercourse to reduce the risk of pregnancy and sexually transmitted infections by providing a physical barrier on the penis.

  • How is the rubber condom (non-colored) supplied and is it reusable?

    It is supplied non-sterile and designed for single-use only; reuse is not recommended as it compromises barrier integrity and increases failure risk.

  • What material is the rubber condom (non-colored) made from and what color is it?

    It is made from natural rubber latex and is specifically non-colored, meaning it contains no added dyes or pigments.