No certification or testing is required for the use of Scrubs in any clinical setting. We would like to ensure that there is clarity to the end user that our Gown is not tested against any specific Certificate and to make the end user aware that there is not Certification requirement for Scrubs Certificate either.
No. It does not need a CE mark because it is for your own individual and personal use.
We need to meet specific Certification to call our Gown either a Medical Device or PPE (Personal Protective Equipment) in the UK. Keeping it simple:
- Surgical Gown – is classed a Medical Device (BS EN 13795:2019)
These are in common use as PPE for the treatment of Covid-19 patients. This Certificate has been designed for safety in a Surgical setting NOT AS PPE. We are of the opinion that standards required in this this Certificate are not appropriate to be used as PPE. Surgical Gowns (single use) have a VERY HIGH air permeability, the air gets through easily – whereas our Gown has a LOW air permeability. There are also required standards within this Certificate e.g. linting, static etc, which are only necessary in a Surgical Setting. Our Gown has not been designed for use in a Surgical Setting – it has been designed to be worn to protect the end user, underneath single use plastic apron/ gown (as appropriate).
- Isolation Gown/ Hazmat Suit etc – PPE (EN 14126:2003)
These are NOT commonly used for the treatment of Covid-19 patients at the current time. There are numerous reasons why: apart from lack of availability, they tend to be heavy, hot & cumbersome which make them ‘hard to wear’ on a Covid-19 ward. Our gown is designed to be worn underneath single use waterproof apron/ gown as appropriate. It is designed to be comfortable enough to be worn for a 12-hour shift with significant levels of manual handling. On the surface – it would ‘appear’ that this would be good Certification for us to look at – unfortunately it isn’t. This Certification is really centered around the highest levels of protection against hazards – our gown is not designed to provide the highest level of protection against infective agents.
We are of the opinion that water resistance and a low air permeability are important qualities in infection control for Covid-19. There currently is not a huge amount of research in this area but please see the following interesting and useful papers.
Effective personal protective clothing for health care workers attending patients with severe acute respiratory syndrome, April 2004
Centers for Disease Control and Prevention: COVID-19 Outbreak Associated with Air Conditioning in Restaurant, Guangzhou, China, 2020
Airborne transmission of SARS-CoV-2: The world should face the reality
Your gown will remain water resistant if you only and always wash it using the NikWax TechWash Product and reproof when required. We expect this to be after 3 washes. Please see https://montrealparkgown.org/the-gown for full laundry care.
You may decide that you do not want to maintain the water-resistant qualities of your Scrub Gown – there may well be several reasons for this. This is totally your decision.
There is further technical data to be found: