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FDA Certified Surgical Masks-ASTM Level 1 Disposable 3-Ply Medical Face Masks

MOQ:200,000pcs

Color: Blue, White, or as requested

Size: 17.5X9.5cm

Material: SBPP,MB,SBPP

Sales Model: Wholesale

Style: Earloop

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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 toFDA510K (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.

surgical mask 01.jpg

surgical mask 02.jpg

nose bridge.jpg



[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.