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Latex Condoms (Natural Colour)

by Reddy Medtech Health Products, Ltd.

510(k) K974326

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974326 Date9 Feb 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LTZ
FDA applicant
Reddy Medtech Health Products , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.5310
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 condom with nonoxynol-9, classified under product code LTZ and regulation number 884.5310. It is a Class II medical device in the Obstetrics/Gynecology specialty, designed as a barrier contraceptive.

The device is supplied as a single-use, non-sterile product made of natural colour latex. It received FDA 510(k) clearance (K974326) on February 9, 1998, through the traditional pathway, and is manufactured by Reddy Medtech Health Products, Ltd. in Plainsboro, New Jersey.

Other devices from Reddy Medtech Health Products, Ltd.

Questions

AI-generated answers, 26 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 LATEX CONDOMS (NATURAL COLOUR) device used for?

    This device is a barrier contraceptive designed to prevent pregnancy and reduce the risk of sexually transmitted infections by providing a physical barrier during sexual intercourse. It contains nonoxynol-9, a spermicide, to enhance contraceptive effectiveness.

  • How is the LATEX CONDOMS (NATURAL COLOUR) supplied and is it sterile or single-use?

    The condom is supplied as a single-use, non-sterile product made of natural colour latex. It is intended for one-time use only and should not be reused, as reuse compromises integrity and increases the risk of breakage or infection.

  • What regulatory pathway and clearance does the LATEX CONDOMS (NATURAL COLOUR) have?

    The device received FDA 510(k) clearance (K974326) on February 9, 1998, through the traditional pathway, and was found substantially equivalent to a predicate device. It is classified as a Class II medical device under product code LTZ and regulation number 884.5310.