3 Ply Level II Mask

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Product Standard:


Factory ISO:

EN ISO 14971:2012

TGA Approval Pending

EC Declaration of Conformity Regulation 93/42/EEC including Directive 2007/47/EC

TESTING ENTITY: Nelson Labs (Test number 1287869-S01)




Model: 3 Ply Level II Mask
Product Code: ROM180
Material: Non woven
Description: Single use, disposable, non sterile intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
Sterilisation: Non Sterile
Size: 17.5cm * 9.5cm
GW: 12Kg
Outer Box Dimensions: 38cm x 30cm x 52cm
Qty Per Carton: 2,000
Box Printing: Outer and Inner
MOQ: 100,000
Colour: Blue
Bacterial Filtration Efficiency (BFE) Test Test Standard: EN 14683:2019+AC:2019(E) Annex B + ASTM F2101-19 Requirements: ≥98 Result:
Specimen 1#: 99.6%
Specimen 2#: 99.3%
Specimen 3#: 99.5%
Specimen 4#: 99.6%
Specimen 5#: 99.3%
Microbial Cleanliness Test Test Standard: t EN 14683:2019+AC:2019(E) Annex D. Requirements: ≤30 Result:
Specimen 1#: 1.9 CFU/g
Specimen 2#: 1.9 CFU/g
Specimen 3#: 2.1 CFU/g
Specimen 4#: 2.2 CFU/g
Specimen 5#: 2.1 CFU/g