3 Ply Level Type IIR Surgical Mask

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Product Standard:


Factory ISO: Required TGA/FDA Approval

EC Declaration of Conformity Regulation 745/2017:2017

TESTING ENTITY: TUV SUD Products Testing (Test number721653313-14)




Model: 3 Ply Level Type IIR Surgical Mask
Product Code: ROM264
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. The surgical masks for medical use are intended to be worn to correct both the patient and healthcare personal from transfer of microorganisms, body fluids and particulate material.
Sterilisation: Non Sterile/Sterile
Size: 17.5cm * 9.5cm
GW: 6.6kg
Outer Box Dimensions: 54 x 36 x 38
Qty Per Carton: 1,600
Box Printing: Outer and Inner
Bacterial Filtration Efficiency (BFE) Test Test Standard: EN 4683:2019 +AC:2019(E) Annex B. Requirements: ≥98 Result:
Specimen 1#: 99.6%
Specimen 2#: 99.5%
Specimen 3#: 99.6%
Specimen 4#: 99.4%
Specimen 5#: 99.3%
Differential Pressure Test Test Standard: EN 14683:2019+AC:2019(E) Annex C. Requirements: <60 Result:
47.0 Pa/cm2
Synthetic Blood Penetration Test Test Standard: ISO 22609:2004. Requirements: None Seen Result:
Specimen 1#-13#
None seen
Microbial Cleanliness Test EN 14683:2019+AC:2019(E) Annex D. Requirements: ≤30 Result:
Specimen 1#: 2 CFU/g
Specimen 2#: <1 CFU/g
Specimen 3#: 2 CFU/g
Specimen 4#: 2 CFU/g
Specimen 5#: <1 CFU/g