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Multiple Brand Male Latex Condom

by Nulatex Sdn. Bhd. Malaysia 510(k)

510(k) K070937 Product code HIS

Overview

A male latex condom is a barrier device intended for contraception and prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections. It is made from natural rubber latex and designed for single-use during sexual intercourse.

The device is supplied non-sterile and intended for use in general consumer settings. It has received FDA 510(k) clearance under product code HIS and regulation number 884.5300, with the manufacturer being Nulatex Sdn. Bhd. No claims regarding MRI safety, reusability, or specific sizes are made in the provided data.

Summary written by AI from registry data, 21 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK070937 Date21 Sep 2007ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

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

Other devices from Nulatex Sdn. Bhd.

See all devices from Nulatex Sdn. Bhd. →

Questions

  • What is the MULTIPLE BRAND MALE LATEX CONDOM intended for?

    The device is a barrier condom intended for contraception and prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections during sexual intercourse.

  • How is the MULTIPLE BRAND MALE LATEX CONDOM supplied and is it sterile?

    The condom is supplied non-sterile and designed for single-use during sexual intercourse, meaning it is not intended to be reused after one use.

  • What material is the MULTIPLE BRAND MALE LATEX CONDOM made from and who manufactures it?

    It is made from natural rubber latex and manufactured by Nulatex Sdn. Bhd., as specified in the device data.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K070937 24 fields · synced 22 Oct 2026