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FDA Certified ASTM Level 1 Surgical Masks

MOQ:200,000pcs for Level 1 Surgical Masks

Color: Blue, White, or as requested

Size: 17.5X9.5cm

Material: SBPP,MB,SBPP

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we’re so confident you’ll love our products that we’ll send you a sample for free. Fill outthis form to get started.

Product Name: FDA Certified ASTM Level 1 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 Performance for ASTM Level 1

Medical Mask:

Standard Class
Breathing Filtration Efficiency (BFE)
Breathing Resistance (mmH20/cm2)
Splash Resistance(mmHg)
Particulate Filtration Efficiency (PFE)
FDA 510K

ASTM F 2100-Level 1

>95% < 5.0 80 >95%

[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.