THE FIRST GLOBAL LINE OF ANTIMICROBIAL RESPIRATOR MASKS

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Transcription:

THE FIRST GLOBAL LINE OF ANTIMICROBIAL RESPIRATOR MASKS GUARDIAN (Valve) DEFENDER PROFESSIONAL PROTECTOR (Child) GUARDIAN N95, N99, FFP2, and FFP3 Reusable up to 14 days** Single Use for extended wear up to 12 hours* Molded and flat-fold designs Adult (large) and children s (small) sizes*** Cleared by the FDA and E.U. (CE Mark) Superior respiratory protection Self-sanitizing for added protection Universal Fit for all facial shapes and sizes Safe, natural & non toxic PVC Free, Latex Free, Non-allergenic * N95 for United States, N99 for Canada, FFP 2 & 3 for European Union ** For European Union & Canada only *** Not for sale in the United States 2

PRODUCT SPECS Antimicrobial Respirator Masks (E.U. Approved with CE Mark) Antibacterial (FDA Approved) Model Guardian FFP3 RD Defender N99 Protector (Child) N99 Guardian FFP2 RD Professional N95 Style Flat-Fold with Valve Molded Molded Flat Fold No Valve Molded Region International International International International United States Reusable up to 14 days Effective Against YES (E.U.) YES (Canada) YES (Canada) YES (E.U.) NO Viruses, Mold, Bacteria, Fungus Viruses, Mold, Bacteria, Fungus Viruses, Mold, Bacteria, Fungus Viruses, Mold, Bacteria, Fungus Bacteria Certifications FFP3 RD CE EN 14683 Type IIR CE EN 149:2001 & A1: 2009 Canadian Type 1 Medical Device Canadian Type 1 Medical Device FFP3 RD CE EN 14683 Type IIR CE EN 149:2001 & A1: 2009 FDA Class II Medical Device NIOSH 42CFR Part 84

BE PROTECTED A powerful sneeze can produce nearly 40,000 aerosol droplets which are propelled through the air at great force. The most common estimates for the speed these droplets travel is around 95 mph, but some people may be able to reach 650 mph for their sneezes. This is the main reason that airborne diseases can be so easily spread throughout the population.

THIS IS HOW IT PROTECTS The SpectraShield Mask, captures microbes, then inactivates or kills them* *Antimicrobial performance inactivates viruses and kills bacteria

The SpectraShield Mask filters over 3,500% better than an ASTM F2100-07 high barrier mask Gaps Around Nose Causes Air Leakage Snug Fit Dual Elastic Straps No Air Leakage Tight Fit Around Nose No Air Leakage No Snug Fit Loose Ear Straps Causes Air Leakage No Filtration Capability Superior Filtration Filters out up to 99% of particulates ASTM F2100-07 High Barrier Surgical Mask SpectraShield Antibacterial N95, Antimicrobial N99, FFP2 & FFP3 Respirators

COMPETITIVE REVIEW The SpectraShield mask is superior to other antimicrobial and antibacterial masks available in the market. Nexera Spectra Shield Kimberly Clark All Masks 3M All Masks Filigent BioMask GSK ActiProtect NIOSH Cleared as a Respirator YES YES YES NO NO Long Lasting Continuous Kill Antimicrobial Agent YES NO NO NO NO Approved for Extended Wear up to 12 Hours in the US by the FDA REUSABLE Certified by EU with a CE Mark Use of Silver & Copper, known natural effective nontoxic antimicrobials for centuries Multiple Respirator Mask Designs including Molded and Flat Fold, valve and non valve YES NO NO NO NO YES NO NO NO NO YES NO NO NO NO YES YES YES NO NO

The SpectraShield Series of Antimicrobial Masks offer: SUPERIOR RESPIRATORY PROTECTION PROTECTION DURING A HEALTH CRISIS REDUCED CROSS CONTAMINATION EASY BREATHING AND COMFORT KILLS TUBERCULOSIS, MRSA, BIRD FLU, SWINE FLU AND MORE * Antimicrobial Masks are NOT available in the United States. Only Antibacterial Masks are available in the United States.

The SpectraShield Mask is Safe and Effective The SpectraShield Mask is: Non-toxic Latex-Free, PVC-Free, and non-allergenic Non-irritating Safe and secure antimicrobial agent that does not gas off or leach off to be inhaled or ingested. All test results were compiled in a Safety Summary Analysis which indicated the SpectraShield Mask to be deemed safe and effective by the FDA. Test Dermal Sensitivity Primary Skin Irritation Systemic Toxicity Gas-Off/Leach-Off Cytotoxicity Fluid Resistant BIOCOMPATIBILITY Outcome Scored 0 on test -No sensitivity Scored 0 on test No irritation Test showed No toxicity No measureable amounts Not toxic to human cells Highly fluid resistant All Biocompatibility Tests were performed in FDA Certified Independent Laboratories

FDA DEEMED SAFE AND EFFECTIVE Revolutionary New FDA-Cleared SpectraShield N95 Antibacterial Surgical Respirator Mask First to Use Antimicrobial Textile Simultaneous clearance by FDA & NIOSH. Tested and proven for extended wear up to 12 hours. The technology eliminated breathing zone concerns of the FDA. Patented technology proven performance. Meets CDC & WHO guidelines for infections disease exposure control. Effective against certain bio-terrorism illnesses such as Tuberculosis. SpectraShield receives clearance for a new class of Antimicrobial Medical Devices called ONT

E.U. DEEMED REUSABLE Revolutionary New European Union Cleared SpectraShield FFP2 RD and FFP3 RD Antimicrobial Respirator Mask First to Use Antimicrobial Textile The FIRST AND ONLY antimicrobial reusable FFP2 & FFP3 respirator masks. Tested and proven for reuse for up to 14 days. Patented technology proven performance. Meets CDC & WHO guidelines for infections disease exposure control. Effective against certain bio-terrorism illnesses such as Tuberculosis. FFP2 RD FFP3 (WITH VALVE IS ALSO AVAILABLE)

The SpectraShield Mask is FDA Cleared With Long-Lasting and Continuous Kill Performance, the SpectraShield Mask: Cleared as an N95 Antibacterial Surgical Respirator Meets requirements for surgical respirator as a Class II Medical Device Tested and proven for Extended Wear with performance up to 12 hours when exposed to sweat and saliva Passed all safety related testing including, toxicity, biocompatibility, gas-off / leach off, fluid resistance, and dermal sensitivity 12

The SpectraShield Mask is CE Certified as a REUSABLE ANTIMICROBIAL FFP2 RD & FFP3 RD MASK CE EN149:2001 & A1:2009 With Long-lasting and Continuous Kill performance, the SpectraShield Mask: CE Cleared as a REUSABLE Antimicrobial Respirator Mask CE Cleared FFP2 RD (no valve) and FFP3 RD (with valve) EN 14683 Type IIR Tested and proven for Extended Wear with performance up to 12 hours when exposed to sweat and saliva Complies with 2008 European Communities Medical Device Directive 93/42/EEC All tests conducted at ISO Certified independent testing facilities in the European Union FFP 2 & FFP3 Reusable Antimicrobial Masks are NOT available in the United States.

The SpectraShield Mask is Canadian Cleared as a N99 Reusable Antimicrobial Respirator With Long-lasting and Continuous Kill performance, the SpectraShield Mask: Cleared as an N99 Reusable Antimicrobial Respirator Reusable up to 14 days Meets requirements for respirator mask as a Class I Medical Device Tested and proven for Extended Wear with performance up to 12 hours when exposed to sweat and saliva Passed all safety related testing including, toxicity, biocompatibility, gas-off / leach off, fluid resistance, and dermal sensitivity N99 Reusable Antimicrobial Masks are NOT available in the United States.