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Mask Viral Filtration Efficiency (VFE) Test

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Mask Viral Filtration Efficiency (VFE) Test

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Service Scope

VFE is not recognized as a standard test method but has been widely adopted by Laboratories from the ASTM F2101 method. It is always used by manufacturers in their marketing literature and in the FDA 510(k) applications for N95 FFRs with an antimicrobial/antiviral agent.  

The test will be conducted in compliance with the following standard 

  • ASTM F2101

This test determines how well a mask filters virus-containing droplets of about 3 microns in size. It is similar to BFE that it uses droplets of similar size, but uses a different challenge organism (bacteriophage instead of bacteria).The higher VFE , the more effective a mask is as a barrier against viruses, including coronaviruses. A mask with a VFE of 95 per cent, for example, blocks 95% of virus-containing droplets it is exposed to.  

Test Plan

Sample Size 
It will be advised in order confirmation email upon purchase

Turnaround Time (working days)
12 Days

Test Description

Viral Filtration Efficiency (VFE) Test according to ASTM F2101method. No PASS/FAIL will be rated (data report only) since no requirements are set under the standard. Generally it is used to show the claim showing on the packaging.

Remarks

Only applicable test items will be conducted on selected product nature and destination market. A detailed test item list will be included in order confirmation email upon order purchase.

Strengths & benefits


Regulatory Experts
Ensure your product compliance to specific countries’ requirements


Global Network
Provide worldwide coverage and access to all key locations & markets

Order flow

1. Check Out

Confirm selections and fill in contact info

2. Arrange Payment

Pay by credit card or bank transfer offline​

3. Confirm Test Plan

Confirm test and product details

4. Send Sample

Send the sample with printed form

5. Receive Report

Receive our test report by email

Payment

Online Payment
  • We accept VISA, MASTERCARD and AMERICAN EXPRESS
  • Order acknowledgment email will be sent to you by system after successful payment
  • Order confirmation email with service details will be sent to you within 1 working day by our specialist
Offline Payment
  • We accept T/T bank transfer payment
  • Order acknowledgment email with bank details for payment will be sent to you by system after order submission
  • Please arrange payment and send payment receipt to our specialist by email
  • Order confirmation email with service details will be sent to you after payment verification by our specialist

FAQs

You can add them to shopping cart and proceed to checkout for placing your order online. You will receive an order acknowledgment with order details after online order.

It is not necessary to create an account for online purchase, you can select Guest Checkout to place an order without an account.

However, creating an account offers additional benefits:

  • Your contact information will be saved securely for a faster checkout
  • Track your order status and history

If you place an order as a guest, please check our notifications at your email box. Please remember to check promotional and junk mail box if you can’t find it.

If you place an order as a member, please log in and check the status of your order under “Quote Request” or “Orders”.

SGS TIC Mall only accepts US$ for checkout.

You will receive a test application form, sample requirement and delivery details in confirmation email upon successful payment, please complete the form and send the required sample(s) to our competence center in Hong Kong.

Please contact your dedicated specialist to submit your request. It will be reviewed case by case depending on the order process.

No, you can’t cancel and refund the paid order unless there is a quality or service delivery issue.

The most common standards shown on mask packaging are BFE, PFE, and VFE. VFE is obtained using 3.0 µm size particles containing phiX 174 as the challenge virus and Escherichia coli as the host.  

“FDA approved” means that the agency has determined that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing to get an approval. FDA approval is usually mandatory when you market or sell the products in the US that might have a significant risk of injury or illness, but can also benefit your health — such as prescription medications, over-the-counter medications, vaccines and Class III medical devices. 

Class II and Class I medical devices are usually “cleared” by the FDA – meaning the manufacturer can demonstrate that their product is “substantially equivalent to another (similar) legally marketed device” that already has an FDA clearance or approval. Companies must submit a “premarket notification submission” or 510(k) to the FDA so that they can review the product and clear it. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is “cleared,” and can be marketed and sold in the US. 

Since the surgical mask is classified as class I medical device, the company has to submit premarket notification 510(k) before they can be sold in the US market.  

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