Certification requirement rules for respiratory protective devices are incorporated in NIOSH, USA (Rule 42 CFR Part 84) and FFP2, Europe (EN-149:2001). On the basis of these rules, two independent labs have approved and certified our product ‘Alpha Face Guard HSN-95 Respirator (Mask)’ confirming the compliance of these rules.
A. Report no. AQC-Labs/11569/20-21 issued by Arham Quality Control Laboratory (AQC Lab). AQC Lab is approved by The Government of India under ‘AGMARK’ and certified by NABL (A Constituent Board of Quality Council of India).
B. Report no. 160520-2 issued by Lilaba Analytical Laboratories, which is accredited by NABL, BIS and FSSAI.
C. World Health Organization - GMP (Good Manufacturing Practice) Certificate
D. ISO Certifications
ISO 45001 : 2018
Occupational Health and Safety Management System
ISO 9001 : 2015
Quality Management System
ISO 13485 : 2012
Medical Devices- Quality Management System