Regulatory Approvals

United States

FDA 510(k) Clearance — SpectraShield™ Defender™ 9500 (Antimicrobial N95 Surgical Respirator)
NIOSH Approval — SpectraShield™ Guardian™ 9500, Guardian™ 9900, Defender™ 9500, Defender™ 9900

The SpectraShield™ 9500 Surgical N95 Respirator received both FDA 510(k) and NIOSH clearance to commercially market in the United States. The mask has been certified to kill Methicillin-resistant Staphylococcus aureus (MRSA), Streptococcus pyogenes, and Haemophilus influenzae.

FDA Approved for 8-Hour Continued Use

Canada

View Full Health Canada Approvals

SpectraShield™ Guardian™ and Defender™ series respirator masks are approved by Health Canada for distribution and sale in Canada.

European Union

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SpectraShield™ Guardian™ FFP2 RD and FFP3 RD respirator masks are EN149 Approved and CE Mark certified for distribution within the European Union.