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ASTM Level 2 Surgical Face Mask

Our surgical face mask with an integrated nose clip have different layer of materials and thickness to correctly reach ASTM F2100 Surgical Mask standard from level 1 to level 3. The masks are made of skin-friendly materials that are comfortable to wear with exceptionally high bacterial filtration efficiency and particle filtration efficiency. We also offer the “tie-back” option for these masks which is ideal to be used for surgical applications.

  • Brand:

    3A
  • Item No.:

    PPE-FM/3PLYUS
  • Color:

    Blue
  • Size:

    17.5 x 9.5cm
  • Material:

    Non-woven and Meltblown
  • Application:

    Hospital and surgical use
  • MOQ:

    2000 unit boxes
  • Lead Time:

    5 to 7 days
  • Shipping Terms:

    FOB
  • Packaging Details:

    50 pcs per unit box, 40 unit boxes per export carton
  • Carton Size:

    52 x 40 x 40 cm / 2000 pieces
  • Shipping Weight:

    9.5 KGS
Description

Since March, 2020 FirstCare has been supplying PPE and Safety Products to customers across the globe in order to get these items to the people in need. Being a professional vendor of first aid supplies and medical devices for almost a decade gave us unique advantages when it comes to building the proper supply chain in this rather crazy market.


We have shipped millions of these ASTM complied surgical face masks to USA. Unlike those who do not even understand the difference between surgical masks and disposable masks, we are distributing products that are properly FDA registered and with 510(k) premarket notification. Email us now to request more details such as test report, FDA registration information and most competitive prices!

Specification

Size

17.5 x 9.5cm (±0.5cm)

Material Specs 3 Layers

PP Non-woven 25gsm ± 1gsm

Melt Blown 25gsm ± 1gsm

PP Non-woven 30gsm ± 1gsm

Packaging

50 pcs / bag packed in a unit box

40 unit boxes per export carton

Carton Measurement

52 x 40 x 40 cm / 2000 pieces

G.W.

9.5 KGS

Standard

ASTM F2100-19 Level 2

Bacterial Filtration Efficiency (BFE)

≥ 98%

Particle Filtration Efficency (PFE)

≥ 98%

Synthetic Blood ASTM F1862,ISO22609

Pass at 120 mmHg

Flammability 16 CFR Part 1610

Class 1 (≥ 3.5 seconds)

Biocompatibility

510(k) Guidance recommends testing to ISO 10993

Product FAQs

Q: Are you registered with FDA and do you have 510K on these level 2 surgical masks?

A: Yes. We are properly registered with FDA including the 510(k) premarket notification. We also have SGS test report for all of our ASTM complied surgical mask.


Q: What is the shelf life of these masks?

A: The shelf life is 2 years from manufacturing date.


Q: Are these reusable surgical face masks?

A: No these are disposable and single-use 3 ply surgical mask.


Q: Do you have a tie-back version of these masks?

A: Yes tie-back surgical masks are optional with a small difference in cost. Please e-mail us for a quote.

Request a Quote

Leave us a message and we’ll put you in touch with the right people to provide you more information as quickly as possible.

Related Products
Non-sterile Medical Surgical Face Mask Type IIR EN14683 Type IIR Surgical Mask
These blue and white 3 ply Face Masks with an integrated nose clip have different layer materials and thicknesses to correctly reach EN14683 Type IIR mask standard. The disposable surgical masks are made of skin-friendly materials and are very comfortable to wear with an exceptionally high bacteria filtration efficiency (BFE) ≥ 98%.
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