Condom

Main information

  • Trade name:
  • Condom, male, latex, lubricated
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Condom, male, latex, lubricated
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218757
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218757

Ausai Pty Ltd - Condom, male, latex, lubricated

ARTG entry for

Medical Device Included Class IIb

Sponsor

Ausai Pty Ltd

Postal Address

9 Forestlea Place,SUNNYBANK HILLS, QLD, 4109

Australia

ARTG Start Date

21/12/2013

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Dong Tai BioMed Industrial Co Ltd

No 1 Second Hailong Road Dongtai Coastal

Economic Region

, Jiangsu Province, 224237

China

Products

1. Condom, male, latex, lubricated

Product Type

Single Device Product

Effective date

21/12/2013

GMDN

45137 Condom, male, latex, lubricated

Intended purpose

A device that is a latex rubber sheath worn to cover the penis during coitus to prevent sperm from gaining

access to the female reproductive tract and/or prevent microorganisms, e.g., those that cause sexually

transmitted diseases, from being transmitted from one user to another. The device is provided with a

compatible lubricant. This is a single-use device.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 09:25:50 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

There are no safety alerts related to this product.

26-9-2018

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health:  https://go.usa.gov/xPDQw 

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw 

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw 

FDA - U.S. Food and Drug Administration

26-9-2018

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide:  https://go.usa.gov/xPDQw  #M

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw  #M

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw  #MedicalDevices

FDA - U.S. Food and Drug Administration

6-8-2018

A reminder about the safe and correct use of condoms

A reminder about the safe and correct use of condoms

A reminder on the safe use of condoms, including making sure you’re aware of the expiry date

Therapeutic Goods Administration - Australia

1-8-2018

Durex Real Feel condoms, 6 pack

Durex Real Feel condoms, 6 pack

Recall - single batch does not pass shelf life durability tests

Therapeutic Goods Administration - Australia