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Tecnical Data Sheet Type II

Tecnical Data Sheet Type II
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Tecnical Data Sheet Type II

Product catalog summary
Product Specifications
Code: VSM10
Product: Surgical Face Mask Type II
Purpose: Designed for medical personnel to limit the transmission of infective agents during surgical and medical procedures.
Performance Characteristics:
  • Bacterial Filtration Efficiency (BFE): Meets EN 14683:2019 standard with BFE ≥ 98%, achieving 99.4%.
  • Differential Pressure (ΔΡ): Complies with EN 14683:2019, with ΔΡ < 40 Pa/cm², measured at 32.9 Pa/cm².
  • Microbial Cleanliness (Bioburden): Adheres to EN 14683:2019 and EN ISO 11737-1:2018, with < 30 CFUs/gr, achieving <19.9 CFUs/gr.
  • Biocompatibility: Follows EN ISO 10993-1:2009.
Material Specifications:
  • Outer Material: Spunbond Polypropylene (SBPP)
  • Filter Material: Melt Blown Polypropylene (MBPP)
  • Inner Material: Spunbond Polypropylene (SBPP)
  • Nose Piece: Plastic Covered Iron
  • Earloop: Polyester and Spandex
Description: Rectangular face masks with shingle pleats, a shapeable nosepiece, and two earloops.
Dimensions:
  • Body Size: Length 175mm, Width 95mm
  • Earloop Length: 135mm
  • Pleat Depth: 10mm
  • Nose-piece Length: 105mm
Packing: 50 masks per box, 24 boxes per case.
Storage Conditions: Store in cool, clean, and dry conditions.
Shelf Life: 3 years
Regulatory Compliance: MDR 2017/745 Class I Medical Device
Contact Information:
Covertex IKE, Thermaikou 52 str VI.PE Efkarpias, Thessaloniki, Greece
Tel: +302310682825
Website: www.vestamed.gr
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Catalog excerpts

Tecnical Data Sheet Type II-1

VESTAMEDPRODUCT SPECIFICATIONSSurgical Face Mask Type II Surgical face mask is intended to be worn by medical personnel during surgical or other medical procedures to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements.

 Open the catalog to page 1
Tecnical Data Sheet Type II-2

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 Open the catalog to page 2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.