Main information

  • Trade name:
  • Non-woven gauze pad, sterile
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Non-woven gauze pad, sterile
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218469
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Medline International Two Australia Pty Ltd - Non-woven gauze pad, sterile

ARTG entry for

Medical Device Included Class IIa


Medline International Two Australia Pty Ltd

Postal Address

PO Box 4366,MARAYONG, NSW, 2148


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Medline Industries Inc

1200 Townline Road One Medline Place

Mundelein, IL, 60060

United States Of America


1. Non-woven gauze pad, sterile

Product Type

Single Device Product

Effective date



48131 Non-woven gauze pad, sterile

Intended purpose

A non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from

non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It

is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface

exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than

basic woven gauze pads.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 10:18:49 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.

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