FDA, NIOSH, CDC & Company Information - Indiana Face Mask

FDA, NIOSH, CDC & Company Information

VENDOR INFORMATION:

LEGAL NAME FSSC LLC
DBA INDIANA FACE MASK
DUNS 11-767-5515
CAGE CODE 8ZEH3
NAICS 339113; 423450


Berry Amendment Compliant: 100% Made in USA, Complete chain of custody


Product Information:

ASTM Level 3 Surgical Mask – SM3 Product Page


     SM3 FDA Information: FDA: 510(K) K202214 FSSC, LLC dba Indiana Face Mask

 

NIOSH N95 Respirator – A105 Product Page


     A105 N95 CDC/NIOSH Information: NIOSH: TC-84A-9272FSSC, LLC dba Indiana Face Mask


Manufacturing Capacity:

70,000+ NIOSH N95 Respirators, 200,000+ ASTM Level 3 Surgical Masks per day


Government Experience


Provided millions of surgical masks and N95 respirators to the State of Indiana throughout 2020 during the heart of the pandemic, and continuing to do so as needed. Indiana Face Mask was able to open a manufacturing plant, achieve certification for both NIOSH N95 respirator and get 510(k) clearance for our surgical mask, in an extremely quick timeline in order to fulfill its obligation.

 

Additional Background

Indiana Face Mask (IFM) produces its own polypropylene melt blown filtration media in-house. This provides the advantage of a constant supply of the most crucial and sought-after raw material. IFM has a full GMP laboratory with top of the industry lab and testing equipment for complete validation of its manufacturing processes.

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