Certified to be compliant with the EU standard EN 149:2001 + A1:2009 FFP2. BIS certification Indian – approved in more than 50 Countries for medical use. These masks are made with the same filtration material as N95 masks – but because they have earloops instead of headbands, they have less seal and cannot be marketed as N95 masks in the US.
This product has not been FDA cleared or approved
It is intended for source control only and not for particle filtration; should not be used in a surgical setting or where significant exposure to liquid, bodily or other hazardous fluids may be expected.
The product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic.
This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
User friendly design, which provides optimum protection and comfort. The mask includes 5 layers of filtering material.
• Universal “C” style Flat fold design • Secure fit with Nose Clip • Comfortable fit with Easy Breathability • Hypoallergenic and Soft • Light weight and compatible with other PPE