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FDA 510K ASTM LEVEL 2 SURGICAL MASK VQN0185W - EAR LOOP
Product ID: VQN0185W
Description
FDA 510K Premarket Approval
Confirm to ASTM F1862, F2101, ASTM F2299 standards
Meets EN14683 Rating – Type II Standard
Not made with natural rubber latex
Nosepiece white aluminum strip covered by PP covering
Softex binding (edge tape)
Light and Breathable Face Masks
Three Layers of Protection
Standard Size Fits Adults
Comfortable Stretchable Ear Loops
Soft material, no odor and no skin irritation
Specifications
Material: 3 Plys ( not made with natural rubber latex): Inner & outer layer - spun-bond polypropylene; Middle layer - melt-blown polypropylene; Nosepiece - white aluminum strip covered by PP covering; Headband - urethane elastic fiber or spun-bond polypropylene
Style: elastic ear bands (Tie-on available)
High Fluid Resistance: 120 mmHg
Filtration Efficiency BFE: Average 99.4%
Filtration Efficiency PFE: Average 99.74% at 0.1μm
Breathability - Delta P: Average 2.7 mmH2O/cm2
Flammability Class: 1
Biocompatibility: ISO10993-5 and ISO10993-10
Color: Blue, Green, White, Pink
Dimension: 17.5cm*9.5cm
Storage: 5 ~ 50 celsius, relative humidity < 90
FDA Registration:
Manufacturer: V&Q Manufacturing Corporation
Registered Establishment Number: 3007479164
Proprietary Name: Non Woven Face Mask
Classification Name: MASK, SURGICAL
Product Code: FXX
Device Class: 2
Regulation Number: 878.4040
Medical Specialty: General & Plastic Surgery
Premarket Submission Number: K173062
Packing:
50pcs/box; 2000pcs/carton; carton size 52*38*30cm; G.W. 8KG; N.W. 7KG