Mask Flammability Test
Mask Flammability Test
From public transport to intensive care units, personal protective equipment (PPE) has never been more important. Protecting people from COVID-19 is the number one priority for individuals, business, organizations and governments. Face masks are now compulsory in many settings.
The test will be conducted in compliance with the following standards according to the selected market
- ASTM F2100
- 16 CFR 1610
SGS can offer testing and certification services to verify your product’s Flammability according to ASTM F2100 & 16 CFR 1610 for compliance with those regulations relevant to the U.S. market.
*No requirement of Flammability test under EU market *
It will be advised in order confirmation email upon purchase
Turnaround Time (working days)
Table below is the overall requirement for U.S. ASTM F2100 and this package will perform Flammability testing according to the U.S. market
ASTM F2100 Classification
Table 1 Medical Face Mask Material Requirements by Performance Level
Bacterial filtration efficiency [%]
Differential pressure [mm H2o/cm2 ]
Sub-micron particulate filtration efficiency at 0.1 micron [%]
Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result#
*-An acceptable quality limit of 4.0% is met for a single sampling plan when 29 or more of the 32 tested specimens show “pass” result.
Only applicable test items will be conducted on selected product nature and destination market. Detailed test item list will be included in order confirmation email upon order purchase. If the battery is included, additional battery requirements shall be arranged.
Strengths & benefits
Ensure your product compliance to specific countries requirement
Provide worldwide coverage and access to all key locations & markets
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.
Surgical masks meeting ASTM Level 2 or Level 3 will be able to filter ≥98% bacteria and 0.1μm particulates, while ASTM Level 1 can only filter ≥95% bacteria。
EN14683 Type I and Type II can filter ≥95% and ≥98% bacteria, Type I has a higher breathability than Type II, both are non-resistant to fluid. Type IR has the same bacteria filtration efficiency as Type I, just as Type IIR and Type II, but Type IR are resistant to fluid.
“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 approval. FDA approval is usually mandatory to market or sell 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, which means the manufacturer can demonstrate that their product is “substantially equivalent to another (similar) legally marketed device” that already has 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.