KOLMI - Op Air One Medical Mask
Medical device : Class 1
Medical mask with ties-on and anti-fog band - Type IIR - MD Class 1 - Made in France
Ref.M34101F-30
-
Dental -
Medical -
Industry -
Hygiene
FEATURES AND BENEFITS
TECHNICAL DESCRIPTION
PRODUCT INFORMATIONS
Features and benefits
- Prevents glasses from fogging up
- Respect for the wearer's skin (absorption of sweat and condensation)
- Exceptional respiratory comfort
- This product is a CE medical device
Technical description
- Type of coverage : Type IIR
- Size / Dimensions : 95 x 175 mm (± 5 mm)
- Type of fasteners : Straps
- Use : Medical
- Made in : France
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
- Clean room ISO 8 production
- ISO 10993-5
- ISO 10993-10
Product features
Brand | Article | Size | Colour |
---|---|---|---|
Kolmi | M34101F-30 | 95 x 175 mm | Blue |
Kolmi | M34301F-30 | 95 x 175 mm | Honeycomb |
Packaging Features
Sub packaging | Packaging |
---|---|
Dispenser box | 6 x 40 |
Dispenser box | 6 x 40 |