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Personal protective equipment

FDA 510K ASTM LEVEL 3 SURGICAL MASK VQN0185

Product ID: VQN0185

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 or Tie-on

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.

Style: elastic ear bands (Tie-on available)

High Fluid Resistance: 160 mmHg (Level 3)

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

documentation:

FDA 510(k) Premarket Notification (pdf)Download
FDA 510K Approval Letter K173062 (pdf)Download
FDA Device Listing (pdf)Download
FDA Establishment Registration (pdf)Download
ASTM F2101-14 BFE Test Results (pdf)Download
ASTM F2299 PFE Test Results (pdf)Download
CE Certification (png)Download
EN ISO 13485 Cert (png)Download
16CFR Part 1610a Flammability Test Result (pdf)Download
ASTM F 1862 160mmHg Level 3 Test Report for VQN0185 (pdf)Download

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(240) 383-0005

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