Available as 3 ply mask with Melt blown filter and inner Hydrophilic layer for a comfortable and soft feeling. EU Market- Manufactured as per EN 14683 standard (Type lll and IR). Registered with the European Union and available for sales and marketing of non-sterile surgical masks. US Market-As per ASTM F 2100 standard (level 2 and 3), Registered with US FDA and available for sales and marketing of non-sterile face masks. Available in multiple colour options and packaging options. Automatic flow wrap packing option available for 1/5/10 pcs.
Following are some of the key performance standards used to manufacture and test our
• EN 149:2001
• ASTM F 2100-Levell, ll and III
• EN 14683-Type I, II, IR
• EN 13795
• AAMI Level-1, II, III and IV
• ASTMF F1671-97A, EN 14126, EN 14605
The company has the following certifications/accreditations
• CE Certification
• US FDA Registration
• ISO 13485 (pending for final certification-Audit completed by SGS)
There are no reviews yet.