KOLMI - Op R Medical Mask
Medical device : Class 1
Medical mask with earloops - Type II - MD Class 1 - Made in France
Ref.M13
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Dental -
Medical -
Industry -
Hygiene
FEATURES AND BENEFITS
TECHNICAL DESCRIPTION
PRODUCT INFORMATIONS
Features and advantages
- Protects the environment from droplets emitted by the wearer
- Tested according to BFE (bacteria), PFE (particles) and VFE (virus) tests
- Kolmi masks feature the exclusive Origami folding and Smile welding for better comfort and a perfect fit on the wearer's face
- This product is a CE medical device
Technical description
- Type of coverage : Type II
- Size / Dimensions : 90 x 175 mm (± 5 mm)
- Type of fasteners : Auricular elastics
- Use : Medical
- Made in : France
-
unsterile
-
single-use
-
without-latex
-
should-not-be-stuck-in-a-damp-place
-
should-not-be-exposed-to-temperature-variations-above-or-below
-
must-not-be-exposed-to-the-sun
-
do-not-use-if-the-packaging-is-damaged
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dispositif-mdical
Product informations
Certifications and standards :
- Manufactured under a certified quality system ISO 13485
- Manufactured under a certified quality system ISO 9001
- Complies with the requirements of European Regulation 2017 745 relating to Medical Devices
- EN 14683 : 2019 + AC: 2019
- Evaluation of microbial contamination according to ISO 11737 : 2018 + A1 : 2021
- ISO 10993-5
- ISO 10993-10
Product features
| Brand | Article | Size | Colour |
|---|---|---|---|
| Kolmi | M13001-30 | 90 x 175 mm | White |
| Kolmi | M13101-30 | 90 x 175 mm | Blue |
| Kolmi | M13201-30 | 90 x 175 mm | Green |
| Kolmi | M14301-30 | 90 x 175 mm | White |
Packaging Features
| Sub packaging | Packaging |
|---|---|
| Dispenser box | 16 x 60 |
| Dispenser box | 16 x 60 |
| Dispenser box | 16 x 60 |
| Dispenser box | 16 x 60 |
