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FDA Certified ASTM Level 2 Disposable 3-Ply Surgical Medical Face Mask
Style |
Earloop |
Size |
17.5*9.5cm |
Material |
3-ply: SBPP, MB, SBPP |
Certification |
FDA 510K, ISO13485 |
Structure |
without face visor |
Type |
without soft foam |
Nose clip |
double wire |
Specification |
1.Conform to FDA510K(No:K101000)
2. Glass fiber-free and latex-free. |
Wellmien Test Result for ASTM Level2
Surgical Mask:
Standard Class |
Breathing Filtration Efficiency (BFE) |
Breathing Resistance (mmH20/cm2) |
Splash Resistance(mmHg) |
Particulate Filtration Efficiency (PFE) |
FDA 510K
ASTM F 2100-Level 2 |
>99% | < 6.0 | 120 | >99% |
[Raw Materials, Structure, and Composition of the Product]:
The surgical mask consists of a mask, a nose clip, and two ear loops. The mask is divided into three layers: the inner and outer layers are polypropylene (PP) non-woven, and the middle layer is polypropylene (PP) melt-sprayed. The nose clip is made of galvanized iron wire with PE material. The ear loops are made of elastic spandex, latex-free.
[Application]:
It covers the user’s mouth, nose, and jaw to provide a physical barrier against the direct penetration of pathogens, microorganisms, body fluids, particles, etc.
we’re so confident you’ll love our products that we’ll send you a sample for free. Fill outthis form to get started.