Our non-sterile ASTM Level 3, three ply ear loop disposable face masks are intended for medical and dental professionals performing oral exams of high-risk patients or procedures involving high levels of spray, splatter, moisture, or airborne particles.

Recognized Performance Standards:
BFE filtration efficiency > 98% @ 0.1micron assures a high level of protection against sources of infection
Fluid resistant at 160mmHg (equivalent to arterial blood pressure)
Latex-free

Manufacturer: EcoGuard Inc.
FDA:

• Registration #: 3016667418
• 510(k) #: K111559

FDA Regulations:

• #: 21 CFR 878.4040(b)
• Name: Surgical Mask
• Class II device
• Code: FXX

Standards Reached:

• ASTM F2101
• EN 14683:2019
• ASTM F2299
• ASTM F1862
• 16 CR 1610

Packaging: 50 masks/box, 40 boxes/case

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