Products

Ooops! Professional Surgical face mask 3 ply Type IIR

Ooops! Professional Surgical face masks are made in the Vajda-Papír Dunaföldvár plant in an ISO844-1 clean room according to the ISO 14644-1 standard. The face masks represent the highest Type IIR level available according to the applied EN 14683: 2019 + AC: 2019 standard, provide three layers of splash protection and have a bacterial filtration efficiency of at least 98 percent. The nose clip, which plays a key role in the fit, is longer than average (120 mm, the average market size is 90 mm), making it easier to shape, providing a perfect fit, face coverage and more comfortable. Customers can access the 50 and 10 face masks in domestic retail chains.
>= 98% BFE Bacterial filtration
efficiency is over 98%
Protection Type IIR
Breathable Three layers of protection,
non-woven fabrics
25 gsm / layer
Comfortable fit High elastic round ear loop, low
pressure, ears more comfortable;
better face sealing due to the
longer 120 mm length of clip for
perfect and comfortable fitting
Medical device ✓ Medical device
Detailed technical documentation, authority registration
Type IIR ✓ Regulated, controlled and validated cleanroom
Applicable standard
EN 14683:2019 + AC:2019
✓ Comply with EN 14683:2019 + AC:2019 standard
Laboratory report – according to EN 14683, Type IIR classified medical device
Made in EU ✓ Made in Europe, made in Hungary
CE ✓ CE marking
EC declaration of conformity – medical device Class I.
Production line:
✓ Line: latest state of art technology (made in Europe)
✓ 600 masks/minute production capacity
✓ 300 million mask / year capacity
✓ automated primary and secondary packaging systems

Cleanroom:
✓ verified Class ISO 8 level according to ISO 14644-1 standard
(classification of air cleanliness)
✓ to eliminate the contamination risk
to keep the material cleanliness