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510(k) Data Aggregation
K Number
K150729Device Name
SpectraShield 9500 Surgical N95 Respirator
Manufacturer
Date Cleared
2015-12-29
(284 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Nexera Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator, and inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
In vitro tests have demonstrated 99.99% inactivation on the surface of the mask when tested against the following seasonal, pandemic, avian, swine influenza viruses: Influenza A subtypes: H1N1 (A/ California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/ Lee/40.
No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
Device Description
The SpectraShield model 9500 Surgical Mask is a molded shape surgical mask composed of 4 layers of material, molded to form the mask. A 2-ply meltblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antibacterial/antiviral agent to provide antibacterial and antiviral performance. The mask has 2 elastic straps (not made with natural latex) and an aluminum nose strip.
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