FFP2 NR Mask

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Product Standard:

EN149:2001+A1:2009

TGA Approval Pending

CE-PC-2004002-188-01-9A

TESTING ENTITY: National Quality Supervision and Testing Centre for Personal Protective Equipment (Test number 2020(D)-0179)

             

Category:

Description

Model: FFP2 NR Mask
Product Code: ROM273
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
1. Packaging (Remarks - packaged in a way that they are protected against damage and contamination before use) Result:Pass
2. Material (Remarks - Material used shall be suitable to withstand handling and wear over the period for which the particle filtering half mask is designed to be used.) Result: Pass
3. Practical Performance (Remarks - The filtering half mask shall undergo practical performance tests under realistic conditions) Result:Pass - no imperfections
4. Finish of parts (Remarks - Parts of the device likely to come into contact with the wearer shall have no sharp edges or burrs.) Result: Pass - no sharp edges or burrs
5. Total inwards leakage (Remarks - Individual exercise results to be <11% for at least 46 out of 50) Result: Pass - 50 out of 50 <11%
6. Total inwards leakage (Remarks - Individual wearer arithmetic means were <8% for 8 out of 10) Result: Pass - 8 out of 10 <8%
7. Penetration of filter material (Remarks - Sodium Chloride test 95 l/min at ≤ 6%) Result: Pass - 0.10%
8. Penetration of filter material (Remarks - Paraffin oil test 95 l/min at ≤ 6%) Result: Pass - 4.75%
9. Compatibility with skin (Remarks - Material may come into contact with the wearer’s skin shall not be know to be likely to cause irritation or any other adverse effect to health.) Result: Pass - No irritation or any other adverse effect to health
10. Flammability ( Remarks - When tested, the particle filtering half mask shall not burn for more than 5s after removal of flame.) Result: Pass - burn for 1s
11. Carbon Dioxide content of the inhalation air (Remarks - The carbon dioxide content of the inhalation air (dead space) shall not exceed an average of 1.0% (by volume)) Result: Pass - 0.4%
12. Head Harness (Remarks - The head harness shall be designed so that the particle filtering half mask can be donned and removed easily. The hear harness shall be adjustable or self adjusting and shall be sufficiently robust to hold the particle filtering half mask firmly in position and be capable of maintain total inward leakage requirements for the device.) Result: Pass - Head harness can be donned and removed easily, adjustable or self adjusting and have sufficiently robust to hold the particle filtering half mask firmly.
13. Breathing resistance (Remarks - Inhalation 30I/min<0.7mbar, Inhalation 95I/min<2.4mbar, Exhalation 160I/min<3.0mbar) Result: Pass - 0.6mbar, 1.6mbar, 1.8mbar