Patient

Main information

  • Trade name:
  • Patient shampooing cap
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Patient shampooing cap
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221682
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221682

Australian Linen Supply T/A Confident Care Products - Patient shampooing cap

ARTG entry for

Medical Device Included Class 1

Sponsor

Australian Linen Supply T/A Confident Care Products

Postal Address

PO Box 420,INGLEBURN, NSW, 1890

Australia

ARTG Start Date

25/03/2014

Product category

Medical Device Class 1

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

Yangzhou Perfect Daily Chemicals Co Ltd

Hangji Industrial Park

Yangzhou, Jiangsu,

China

Products

1. Patient shampooing cap

Product Type

Single Device Product

Effective date

25/03/2014

GMDN

47303 Patient shampooing cap

Intended purpose

A cap made of plastic and textile materials, pre-treated with a dedicated detergent mixture that is placed

on the head of a patient to clean the hair by massaging it on the scalp. It is designed to be rinse free for

ease of use on incapacitated patients.

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 02.12.2017 at 04:20:52 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

14-3-2019

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14-3-2019

Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

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22-2-2019

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

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14-2-2019

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Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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21-12-2018

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21-12-2018

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20-12-2018

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20-12-2018

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

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18-12-2018

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11-12-2018

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10-12-2018

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10-12-2018

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9-12-2018

TachoSil

TachoSil

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FDA - U.S. Food and Drug Administration

4-12-2018

FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

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FDA - U.S. Food and Drug Administration

29-11-2018

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28-11-2018

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FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

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FDA - U.S. Food and Drug Administration

27-11-2018

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26-11-2018

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FDA - U.S. Food and Drug Administration

15-3-2019

We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee.  https://go.usa.gov/xE6WG 

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FDA - U.S. Food and Drug Administration

15-3-2019

#FDA CDRH is responsible for protecting and promoting the public health.  We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.  #MedicalDevice

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FDA - U.S. Food and Drug Administration

1-3-2019


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28-2-2019

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FDA - U.S. Food and Drug Administration

22-2-2019

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A4. Patients & caregivers can share their stories and experiences living with a rare disease directly with #FDA through Rare Disease Listening Session pilot program. Learn more: https://go.usa.gov/xEECU  #NIHchatpic.twitter.com/mVptIt3bTI

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FDA - U.S. Food and Drug Administration

22-2-2019

A1. #FDA has many avenues in which patients and caregivers can share the challenges of living with a rare disease with the Agency. Learn more  https://youtu.be/IKOPEMQYdkI  #NIHchatpic.twitter.com/N8ZTj5gVV6

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FDA - U.S. Food and Drug Administration

21-2-2019


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Europe - EMA - European Medicines Agency

21-2-2019


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Europe - EMA - European Medicines Agency

20-2-2019


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Europe - EMA - European Medicines Agency

18-2-2019

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Medicine sponsor decision tree

Therapeutic Goods Administration - Australia

15-2-2019

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FDA - U.S. Food and Drug Administration

8-2-2019

#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA  's Center for Devices and Radiological Health on the agency’s continuing efforts to educate patients on known risk of lymphoma from breast  implants:  https://go.usa.gov/xERN3   #MedicalDevic

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FDA - U.S. Food and Drug Administration

1-2-2019


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Europe - EMA - European Medicines Agency

31-1-2019

Today @US_FDA issued a safety communication to providers and patients  about the risks of air-in-line when using infusion pumps, rapid  infusers, and fluid warmers. Find out more about the risks and #FDA  recommendations:  https://go.usa.gov/xE9g7  ##Medi

Today @US_FDA issued a safety communication to providers and patients about the risks of air-in-line when using infusion pumps, rapid infusers, and fluid warmers. Find out more about the risks and #FDA recommendations: https://go.usa.gov/xE9g7  ##Medi

Today @US_FDA issued a safety communication to providers and patients about the risks of air-in-line when using infusion pumps, rapid infusers, and fluid warmers. Find out more about the risks and #FDA recommendations: https://go.usa.gov/xE9g7  # #MedicalDevice pic.twitter.com/lLIyoG6680

FDA - U.S. Food and Drug Administration

23-1-2019


No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life

No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life

No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life

Europe - EMA - European Medicines Agency

7-1-2019

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

The TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

19-12-2018

The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.

The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.

The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.

FDA - U.S. Food and Drug Administration

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue

Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue

Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Europe - EMA - European Medicines Agency

30-11-2018

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of  blood glucose monitors to empower patients with diabetes with reliable  tools to manage their health. Read more:  https://go.usa.gov/xPMyA   #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

FDA - U.S. Food and Drug Administration

26-11-2018

We aim to efficiently advance beneficial technology to patients, while solidifying FDA’s gold standard for safety. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest demonstrated improvement

We aim to efficiently advance beneficial technology to patients, while solidifying FDA’s gold standard for safety. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest demonstrated improvement

We aim to efficiently advance beneficial technology to patients, while solidifying FDA’s gold standard for safety. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest demonstrated improvements and advances in safety.

FDA - U.S. Food and Drug Administration

26-11-2018

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devic

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devic

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devices.

FDA - U.S. Food and Drug Administration