Surgical Face Mask Type IIR

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Surgical Face Mask Type IIR

Product catalog summary

Product Specifications

Code: VMM 500

Product: Surgical Face Mask Type IIR

This surgical face mask is designed for use by medical personnel during surgical or medical procedures to prevent the transmission of infectious agents from staff to patients.

Performance Characteristics:

Bacterial Filtration Efficiency (BFE): Meets EN 14683:2019 standard with a 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 standards, with < 30 CFUs/g, achieving <19.9 CFUs/g.
Splash Resistance: Passes EN 14683:2019 with ≥ 16 kPa.
Biocompatibility: Conforms to EN ISO 10993-1:2009.

Material Specifications:

Outer Material: Spunbond Polypropylene (SBPP), splash resistant.
Filter Material: Melt Blown Polypropylene (MBPP).
Inner Material: Spunbond Polypropylene (SBPP).
Nose Piece: Plastic Covered Iron.
Earloop: Polyester and Spandex.

Description: The mask features shingle pleats, a shapeable nosepiece, and two earloops for secure placement.

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: Classified as a Class I Medical Device under MDR 2017/745.

Catalog excerpts

PRODUCT SPECIFICATIONS Surgical Face Mask 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. Characteristic Acceptable limit Bacterial Filtration Efficiency (BFE) Microbial cleanliness (bioburden) Specification Outer Material Filter Material Melt Blown Polypropylene (MBPP) Inner Material Mask Body Spunbond Polypropylene (SBPP), splash resistant Spunbond Polypropylene (SBPP) Nose piece Earloop Description Plastic Covered Iron Polyester and Spandex Shingle pleats rectangular face masks with a shapeable nosepiece and two earloops present, one on each side, in order to hold mask in place. Body Size Storage Conditions Nose-piece Length Packing Earloop Length Pleat Depth Boxes / Case Store under cool, clean and dry conditions

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Shelf Life MDR 2017/745 Class I Medical Device

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