Material standards for med-tech gloves

J

johan.stenstrom

#1
Hi,

I'm wondering if there are any material standards that are applicable on clothes, and more specifically med-tech gloves? Our product uses, among others: elastane, polyurethane, polyamide, polyester, nylon and pig leather. All may come in contact with human skin.

All the best,
Johan
 
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M

MIREGMGR

#2
Re: Material standards

Have you reviewed the EN 455 series for applicable requirements and references?

We don't have EN 455 on hand since we don't do gloves, but it's mentioned in the Scope section of ISO 13795-1:2002 (E) as having that applicability.
 
J

johan.stenstrom

#3
Thanks for the reply,

However, our glove is not a disposable and not for "doctor-patient situations", but instead an aid for everyday people.
 
T

temujin

#4
Hi,

Are you sure that your gloves fall under the scope of the Medical Devices Directive? Could it also be personal protective equipment?

Because medical devices are expensive, there is no need to market your device a a Medical Device unless you really have to(Compare your intended use to the scope.)

If your gloves are Medical Devices, you would definitely take a look at the ISO 10993 series on biocompatibility.

regards
t.
 
R

Roland Cooke

#6
Yep, they are definitely medical devices. I'll have a look at ISO 10993, thanks!

So if not for doctor-patient interaction, but for "everyday" use, what is the clinical purpose?
(I'm guessing maybe you mean they would be something like part of a first aid kit, to be worn by a soccer coach when treating an injured player?)

In that case, the coach is the "doctor", and the "player" is the patient. The gloves will be on the borderline of the MDD and PPE since they are protecting both the coach and the player.
 
J

johan.stenstrom

#7
It's actually a grip strengthening glove. Have a look at bioservo.com for more information :)
 
T

temujin

#8
Hi,

I assume you classify the clove under the "third bullet" then...

93/42/EEC said:
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
I had a look at the web site you referred to and I still doubt that we are dealing with a medical device, or even with a personal protective equipment.
Even though it is "modifying a body function" (the grip), it is not, as far as I understand, intended for therapautic or diagnostic purposes.

A hammer or a screwdriver is "modifying" a body function the same way, but it is not a medical device.
I might be wrong on this though, my common sense still tells me this is not a medical device... :)

However, the glove will fall under the Low Voltage Directive.

regards
t.
 
R

Roland Cooke

#9
It may be argued that the glove is for the alleviation of a handicap or disease.

Johan, those materials all sound fairly well-established, but I would be concerned from a prolonged duration perspective.

Maybe start with the material manufacturers themselves, see if they already have this information?
 
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