Document ID: FDA-2009-N-0333-0002
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-10-21T04:00Z

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<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:73.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">QUICK-MED TECHNOLOGIES, INC.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:83.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">3427 S.W. 42</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.05pt;top:82.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.98pt">nd</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:424.25pt;top:83.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Way</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:93.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Gainesville, FL 32608 USA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:103.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="0000ff"><FONT STYLE="font-size: 7.98pt">Website: www.quickmedtech.com</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:61.90pt;top:43.85pt;z-index:2;"><IMG WIDTH=294 HEIGHT=279 style="width:121pt;height:108pt;" SRC="outputfile-1903567309.htm_files\outputfile-1903567309_p0.jpg"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.00pt;top:742.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:174.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">May 10, 2007</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:199.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Via FedEx</FONT></FONT></u></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:227.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Document Mail Center (HFZ-401)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:240.90pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Center for Devices and Radiological Health</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:254.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Food and Drug Administration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:268.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">9200 Corporate Boulevard</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:282.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Rockville, MD  20850</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:309.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Re:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:309.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">K060662 Request for Evaluation of Automatic Class III Designation Under</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:323.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">513(f)(2)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:351.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dear Sir or Madam:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:378.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Quick-Med Technologies is submitting an original and two copies of this request</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:392.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">on the above-referenced 510(k). This document is based on the OCP letter dated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:406.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">April 11, 2007, which was received on April 16, 2007.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:433.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Quick-Med Technologies believes that the QMT NIMBUS Barrier Gauze</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:447.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dressing should be classified as a Class II device subject to both general and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:461.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">special controls, and the 510(k) premarket notification requirements and QSR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:475.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">regulations.   During a telephone conversation with Ms. Leigh Hayes in OCP, it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:489.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was stated that the QMT NIMBUS Barrier Gauze Dressing represents a low risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:502.90pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">device and does not fit the definition of a Class III device requiring a PMA,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:516.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">therefore a De Novo petition is being filed at FDA’s request.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:544.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We appreciate FDA’s cooperation in this matter.  If you have any questions or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:558.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">need further information please contact the undersigned at 630-214-9819 or email</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:571.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">roy.carr@comcast.net.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:613.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Very truly yours,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:654.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Roy Carr</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:695.90pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Attachments: K060662 Appendices 8-11</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:0.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1903567309.htm_files\outputfile-1903567309_background0.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:865.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">QUICK-MED TECHNOLOGIES, INC.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:875.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">3427 S.W. 42</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.05pt;top:874.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.98pt">nd</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:424.25pt;top:875.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Way</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:885.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Gainesville, FL 32608 USA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:895.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="0000ff"><FONT STYLE="font-size: 7.98pt">Website: www.quickmedtech.com</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:61.90pt;top:835.85pt;z-index:2;"><IMG WIDTH=294 HEIGHT=279 style="width:121pt;height:108pt;" SRC="outputfile-1903567309.htm_files\outputfile-1903567309_p0.jpg"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.00pt;top:1534.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:952.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">510(k) Number for NSE Finding</FONT></FONT></u></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:980.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Quick-Med Technologies respectfully requests that premarket notification number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:993.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">K060662 be considered for a risk based classification of the QMT NIMBUS Barrier</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1007.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Gauze Dressing.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1035.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Statement of Cross-Reference to 510 (k)</FONT></FONT></u></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1062.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Quick-Med Technologies hereby cross-references information contained in 510(k)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1076.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">K060662 and RFD070711.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1104.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Classification Being Recommended</FONT></FONT></u></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1131.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Quick-Med Technologies believes the documentation presented in premarket notification</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1145.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">K060662 and RFD070711 is adequate to substantiate an order classifying the QMT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1159.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NIMBUS Barrier Gauze Dressing as Class II (general and special controls) pursuant to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1173.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Section 513 of the Federal Food, Drug and Cosmetic Act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1200.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The QMT Nimbus Barrier Gauze Dressing is similar to the predicate cited in K060662 in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1214.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all respects, including the intended use, except that in our dressing the antimicrobial is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1228.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">bound to the substrate and non-leachable.   The predicate device described in K060662 is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1242.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also classified as a Class II device subject to both 510(k) Premarket notification and QSR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1255.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">requirements and  both general and special controls.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1283.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Benefit/Risk Assessment</FONT></FONT></u></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1310.90pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It is well known that gauze is not an effective barrier to bacteria and other pathogenic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1324.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">organisms. It has been shown that bacteria can penetrate up to 64 layers of dry gauze.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1338.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Wound infections are an important consideration for all wound types. Most wounds are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1352.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">still being treated with gauze dressings. It is an important benefit to help contain wound</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1366.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infections. One way to do this is by treating the gauze with a safe, yet effective, broad</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1379.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">spectrum antimicrobial agent such as with the QMT NIMBUS technology.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1407.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The antimicrobial in the QMT NIMBUS dressing is pDADMAC, a high molecular</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1421.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">weight polymer with high charge density.  The primary mode of action of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1435.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pDADMAC is to physically disrupt the prokaryotic cell wall at the immediate surface of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1448.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the dressing. The polymer does not change chemically when it kills bacteria nor is it a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1462.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">treatment for the wound itself as it is contained in the dressing and unlike other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1476.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antimicrobial substances does not leach out. The pDADMAC monomer, which is more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1490.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reactive and mobile than the polymer, has been extensively tested for safety and has</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:792.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1903567309.htm_files\outputfile-1903567309_background1.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:1584.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:1657.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">QUICK-MED TECHNOLOGIES, INC.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:1667.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">3427 S.W. 42</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.05pt;top:1666.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.98pt">nd</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:424.25pt;top:1667.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Way</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:1677.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Gainesville, FL 32608 USA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:1687.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="0000ff"><FONT STYLE="font-size: 7.98pt">Website: www.quickmedtech.com</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:61.90pt;top:1627.85pt;z-index:2;"><IMG WIDTH=294 HEIGHT=279 style="width:121pt;height:108pt;" SRC="outputfile-1903567309.htm_files\outputfile-1903567309_p0.jpg"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.00pt;top:2326.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1744.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">passed all requirements. Over 500 tons of the polymer form are safely used for potable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1758.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">water treatment every year. The safety profile is well documented for pDADMAC as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1772.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">described in K060662.  The benefit of the QMT dressing is that the microbial action</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1785.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">occurs when the microbes contact the surface of the dressing and does not rely on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1799.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">“leaching” out of an antimicrobial substance. The QMT NIMBUS Barrier Gauze</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1813.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dressing will help protect the patient’s wound from exogenous microbial contamination.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1840.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Several antimicrobial dressings are legally on the market and currently in commercial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1854.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">distribution in the US.   All of the antimicrobial dressings have some risk of developing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1868.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antimicrobial resistance. The silver, PHMB (polyhexamethylene biguanide) or other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1882.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">components used in the currently marketed antimicrobial dressings can leach out of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1896.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">dressing and create a weak outer edge of antimicrobial where resistance can develop.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1909.90pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The leachability is depicted by the Zone of Inhibition that is advertised and promoted by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1923.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the companies with silver, PHMB or other antimicrobials in their dressings. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1937.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antimicrobial in the QMT NIMBUS Barrier Dressing is bound to the substrate and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1951.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">demonstrates no Zone of Inhibition (as depicted in K060662 Section 18).   The NIMBUS</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1965.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">technology remains at full strength in the dressing and thus reduces the risk of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1978.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antimicrobial resistance.   In addition to this benefit, unlike most other legally marketed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:1992.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antimicrobial wound dressings, the QMT NIMBUS Dressing was found to be non-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2006.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cytotoxic during biocompatibility testing (ISO 10993).   Silver containing wound</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2020.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">dressings are consistently found to be cytotoxic due to the cells reaction to silver.   The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2034.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">QMT NIMBUS Dressing provides a non-cytotoxic wound dressing alternative to the use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2047.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of silver in the treatment of wounds.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2075.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This information together with the additional information and documentation disclosed in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2089.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">K060662 and the RFD070011 clearly demonstrates the low risk and benefits of the QMT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2102.90pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NIMBUS Barrier Gauze Dressing.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2130.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There are no known direct risks to the patient’s health associated with the QMT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2144.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NIMBUS Barrier Gauze Dressing. However, as with all medical devices, failure to use as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2158.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">directed by product labeling could lead to less satisfactory wound care. The following are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2171.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">potential risks and mitigation steps:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:2199.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2199.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Improper use. The risk mitigation is device labeling consistent with current FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2213.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">guidance for wound dressings to ensure proper use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:2227.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2227.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Allergic tissue reaction. The risk mitigations include the evaluation of device</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2240.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">biocompatibility and adequate device labeling to ensure proper use.</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:1584.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1903567309.htm_files\outputfile-1903567309_background2.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:2376.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:2449.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">QUICK-MED TECHNOLOGIES, INC.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:2459.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">3427 S.W. 42</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.05pt;top:2458.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.98pt">nd</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:424.25pt;top:2459.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Way</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:2469.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Gainesville, FL 32608 USA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:2479.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="0000ff"><FONT STYLE="font-size: 7.98pt">Website: www.quickmedtech.com</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:61.90pt;top:2419.85pt;z-index:2;"><IMG WIDTH=294 HEIGHT=279 style="width:121pt;height:108pt;" SRC="outputfile-1903567309.htm_files\outputfile-1903567309_p0.jpg"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.00pt;top:3118.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2536.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Proposed General and Special Controls</FONT></FONT></u></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2564.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Quick-Med Technologies believes that General Controls (Establishment Registration,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2577.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Device Listing and Labeling) and Special Controls (labeling requirements for wound</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2591.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">dressings and performance standards such as biocompatibility and antimicrobial testing)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2605.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and compliance with both the 510k and QSR requirements are appropriate for the QMT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2619.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NIMBUS dressing.  These requirements in addition to the risk mitigations described</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2632.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">above for the QMT NIMBUS Barrier Gauze Dressings constitute adequate information to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2646.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ensure reasonable assurance of the safety and effectiveness of the QMT NIMBUS Barrier</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2660.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Gauze Dressing assessed in K060662. These controls parallel the safety and effectiveness</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2674.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">information provided in K060662 for the intended use, as stated in the submission:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2702.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Intended Use</FONT></FONT></u></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:88.50pt;top:2729.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">QMT NIMBUS Barrier Gauze Dressing is intended for use as a primary dressing for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2743.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">exuding wounds, first and second degree burns, and surgical wounds, to secure and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2757.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">prevent movement of a primary dressing, and as a wound packing.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2798.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Performance Testing:</FONT></FONT></u></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2812.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The QMT NIMBUS Barrier Dressing was subjected to and passed all biocompatibility</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2826.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and toxicological tests in accordance with ISO 10993-1 with the lowest possible results in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2839.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">each case.  The protocols and test results of this testing were provided in the Appendices</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:2853.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of K060662 (enclosed herein) and are summarized below:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:2881.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2881.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Cytotoxity Agar diffusion test, ISO 10993-5, 1999.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:406.70pt;top:2881.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The NIMBUS Dressing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2895.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">material was found to elicit no response from the L929 mammalian cell line at 48</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2908.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">h post exposure to the test article: a grade 0 response was found at all time points.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2922.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The NIMBUS Dressing material was determined by Toxikon labs to be non-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2936.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cytotoxic.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:2956.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">2.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2956.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Intracutaneous Injection Test, ISO 10993-10, 2002.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:431.00pt;top:2956.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The extracts from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2970.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NIMBUS Dressing material were found to elicit no significantly greater</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2983.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">biological reaction than animals (New Zealand White rabbits) treated with control</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2997.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">articles.  No signs of toxic response were found at any time point: there was zero</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3011.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">incidence of erythema / eschar and zero incidence of edema, either for NaCl</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3025.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">extract media, or for cottonseed oil extract media.  The NIMBUS Dressing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3039.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">material was determined by Toxikon labs to pass this test.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3058.90pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">3.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3058.90pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Kligman Maximization Test (also known as sensitization), ISO 10993-10993-</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3072.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">10, 2002.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:192.20pt;top:3072.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The NIMBUS Dressing material extract elicited no reaction at the</FONT></FONT></FONT></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:2376.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1903567309.htm_files\outputfile-1903567309_background3.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:3168.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:3241.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">QUICK-MED TECHNOLOGIES, INC.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:3251.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">3427 S.W. 42</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.05pt;top:3250.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.98pt">nd</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:424.25pt;top:3251.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Way</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:3261.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Gainesville, FL 32608 USA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:3271.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="0000ff"><FONT STYLE="font-size: 7.98pt">Website: www.quickmedtech.com</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:61.90pt;top:3211.85pt;z-index:2;"><IMG WIDTH=294 HEIGHT=279 style="width:121pt;height:108pt;" SRC="outputfile-1903567309.htm_files\outputfile-1903567309_p0.jpg"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.00pt;top:3910.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3328.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">challenge (0 % sensitization), following the induction phase.  There were no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3342.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">readings of toxicity, and the scores for all the test animals at all test time points</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3356.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were 0.  As defined by the scoring system of Kligman, this is categorized as a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3369.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">grade I reaction, and the test article is classified as having weak allergenic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3383.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">potential.  The Grade I sensitization is not considered significant according to this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3397.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">test.  The NIMBUS Dressing material was determined by Toxikon labs to pass</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3411.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this test.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:108.00pt;top:3431.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3431.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Systemic Injection Test, ISO 10993-11, 1993.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.00pt;top:3431.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The NIMBUS Dressing material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3444.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was found to elicit no significantly greater biological reaction than animals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3458.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">(Albino Swiss mice) treated with control articles.  No signs of toxic response were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3472.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">found at any time point.  The NIMBUS Dressing material was determined by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3486.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Toxikon labs to pass this test.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3519.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Antimicrobial Effectiveness tests were described in Section 18 of K060662. Quick-Med</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3533.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">has conducted extensive performance testing on the NIMBUS Dressing material.  Test</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3547.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">results are presented in Table 1 which includes a range of bacterial species selected for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3561.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">their likely occurrence in wound environments.  Depending on the information desired</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3574.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from testing, either AATCC method 100 was used, or ASTM E2315-03 for time-kill data.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3588.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The protocols used are indicated. The log kills detailed vary because the growth rates of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3602.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the bacteria are different.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3643.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">Table 1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:3656.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.98pt">Summary of Antimicrobial Testing for the NIMBUS Wound Dressing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:3669.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Method</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3669.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Test </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">species</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:3669.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">ATCC </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">#</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.75pt;top:3669.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 10.02pt">Average Lo</FONT></u><FONT STYLE="font-size: 10.02pt">g </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Kill</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3669.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Note</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3668pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3668pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3668pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3668pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:3668pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3669pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:3669pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:3669pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3669pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3669pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:3669pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3680pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3680pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3680pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3681pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:3681pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:3681pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3681pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3681pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:3681pt;width: 1pt;height:11pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:3693.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">ASTM E2315-03</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.15pt;top:3693.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Methycillin</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.40pt;top:3693.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">resistant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3705.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">staphylococcus aureus</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:260.80pt;top:3705.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3716.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">MRSA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:3693.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">BAA-44</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.75pt;top:3693.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">5.89</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3693.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Time kill, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3705.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">279</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3692pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3692pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3692pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3693pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:3693pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:3693pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3693pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3693pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:3693pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:3728.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3728.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Methycillin</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.35pt;top:3728.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">resistant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3740.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">staphylococcus aureus</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:260.80pt;top:3740.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3751.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">MRSA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:3728.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">BAA-44</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.75pt;top:3728.65pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">6.06 Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3740.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">L0805</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3727pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3727pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3727pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3728pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:3728pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:3728pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3728pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3728pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:3728pt;width: 1pt;height:34pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:3763.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3763.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Staphylococcus aureus</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:3763.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">6538</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.75pt;top:3763.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">7.10 Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3775.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">275</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3762pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3762pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3762pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3763pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:3763pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:3763pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3763pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3763pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:3763pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:3787.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3787.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Escherichia coliform</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:3787.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">15597 7.10  Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3798.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">275</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3786pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3786pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3786pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3786pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:3786pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:3786pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3786pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3786pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:3786pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:3810.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3810.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Pseudomonas</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3822.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">aeruginosa</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:3810.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">15442 7.22  Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3822.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">275</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3809pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3809pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3809pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3810pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:3810pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:3810pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3810pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3810pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:3810pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:3834.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">ASTM E2315-03</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3834.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Staphylococcus aureus</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:3834.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">6538</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.75pt;top:3834.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">6.14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3834.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Time kill, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3845.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">268</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3833pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3833pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3833pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:3833pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:3833pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:3833pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:3833pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:3833pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:3833pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:3857.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">ASTM E2315-03</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:3857.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Escherichia coliform</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:3857.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">15597</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.75pt;top:3857.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">6.58</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3857.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:486.45pt;top:3857.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">kill, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:3869.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">269</FONT></FONT></FONT></SPAN>
<span style="position:absolute;font-size:0;left:71pt;top:3856pt;width:287pt;height: 1pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:359pt;top:3856pt;width:89pt;height: 1pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:449pt;top:3856pt;width:91pt;height: 1pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:71pt;top:3857pt;width: 1pt;height:23pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:71pt;top:3880pt;width:90pt;height: 1pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:162pt;top:3857pt;width: 1pt;height:23pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:162pt;top:3880pt;width:105pt;height: 1pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:268pt;top:3857pt;width: 1pt;height:23pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:269pt;top:3880pt;width:89pt;height: 1pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:359pt;top:3857pt;width: 1pt;height:23pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:359pt;top:3880pt;width:89pt;height: 1pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:449pt;top:3857pt;width: 1pt;height:23pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:449pt;top:3880pt;width:90pt;height: 1pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:539pt;top:3857pt;width: 1pt;height:23pt;background-color:#000000;"></span><span style="position:absolute;font-size:0;left:539pt;top:3880pt;width: 1pt;height: 1pt;background-color:#000000;"></span><span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:3168.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-1903567309.htm_files\outputfile-1903567309_background4.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:3960.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:4033.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">QUICK-MED TECHNOLOGIES, INC.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:4043.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">3427 S.W. 42</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:417.05pt;top:4042.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.98pt">nd</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:424.25pt;top:4043.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Way</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:4053.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.98pt">Gainesville, FL 32608 USA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:373.10pt;top:4063.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="0000ff"><FONT STYLE="font-size: 7.98pt">Website: www.quickmedtech.com</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:61.90pt;top:4003.85pt;z-index:2;"><IMG WIDTH=294 HEIGHT=279 style="width:121pt;height:108pt;" SRC="outputfile-1903567309.htm_files\outputfile-1903567309_p0.jpg"></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:303.00pt;top:4702.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4120.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">ASTM E2315-03</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4120.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Pseudomonas</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4132.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">aeruginosa</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4120.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">15442</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.75pt;top:4120.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">6.41</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4120.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:486.45pt;top:4120.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">kill, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4132.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">270</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4120pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4120pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4120pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4120pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4120pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4120pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4120pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4120pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4120pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4120pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4120pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4144.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4144.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Corynebacterium</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4155.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">xerosis</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.35pt;top:4144.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">7711</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.70pt;top:4144.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">5.68  Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4155.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">271</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4143pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4143pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4143pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4144pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4144pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4144pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4144pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4144pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4144pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4167.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4167.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Micrococcus luteus</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4167.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">21102</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.70pt;top:4167.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">6.02</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.65pt;top:4167.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4179.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">271</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4167pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4167pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4167pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4167pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4167pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4167pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4167pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4167pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4167pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4191.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4191.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Proteus vulgaris</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4191.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">29905</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.70pt;top:4191.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">7.53</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.65pt;top:4191.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4202.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">227</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4190pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4190pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4190pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4191pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4191pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4191pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4191pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4191pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4191pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4214.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4214.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Streptococcus</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4226.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">pyogenes</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4214.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">10096 5.81  Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4226.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">227</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4214pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4214pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4214pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4214pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4214pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4214pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4214pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4214pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4214pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4238.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4238.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Enterococcus faecalis</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4238.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">10741</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.70pt;top:4238.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">6.26</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.65pt;top:4238.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4249.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">227</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4237pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4237pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4237pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4238pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4238pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4238pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4238pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4238pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4238pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4261.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4261.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Enterobacter</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4273.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">aerogenes</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:209.30pt;top:4273.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">, alternately</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4284.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">known as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:218.65pt;top:4284.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Aerobacter</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4296.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">aerogenes</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4261.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">13048 5.88  Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4273.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">208</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4261pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4261pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4261pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4261pt;width: 1pt;height:46pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4261pt;width: 1pt;height:46pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4261pt;width: 1pt;height:46pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4261pt;width: 1pt;height:46pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4261pt;width: 1pt;height:46pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4261pt;width: 1pt;height:46pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4308.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4308.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Staphylococcus</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4319.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">epidermidis</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4308.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">12228 7.44  Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4319.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">208</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4307pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4307pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4307pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4308pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4308pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4308pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4308pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4308pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4308pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4331.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4331.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Listeria monocytogenes</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4331.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">13932 6.97  Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4343.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">159</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4331pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4331pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4331pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4331pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4331pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4331pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4331pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4331pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4331pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4355.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4355.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Enterococcus faecium</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4355.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">700221</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.80pt;top:4355.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">5.2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.80pt;top:4355.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4366.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">L0805</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4354pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4354pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4354pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4355pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4355pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4355pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4355pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4355pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4355pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4378.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4378.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Serratia marescens</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4378.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">13880</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.70pt;top:4378.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">6.21</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.65pt;top:4378.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4390.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">291</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4378pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4378pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4378pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4378pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4378pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4378pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4378pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4378pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4378pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:77.40pt;top:4402.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">AATCC 100-1999</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:168.10pt;top:4402.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Klebsiella pneumoniae</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:274.40pt;top:4402.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">13883</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:364.70pt;top:4402.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">7.35</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.65pt;top:4402.30pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">Swatch test, assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:454.75pt;top:4413.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.02pt">291</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4401pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4401pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4401pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4402pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4402pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4402pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4402pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4402pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4402pt;width: 1pt;height:23pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4425pt;width:287pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4425pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4425pt;width:91pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4425pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:71pt;top:4437pt;width:90pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4425pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:162pt;top:4437pt;width:105pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:268pt;top:4425pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:269pt;top:4437pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4425pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:359pt;top:4437pt;width:89pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4425pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:449pt;top:4437pt;width:90pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4425pt;width: 1pt;height:12pt;background-color:#000000;"></SPAN><SPAN STYLE="position:absolute;font-size:0;left:539pt;top:4437pt;width: 1pt;height: 1pt;background-color:#000000;"></SPAN><SPAN STYLE="color:#000000;position:absolute;left:93.30pt;top:4465.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Summary:</FONT></FONT></u></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4493.10pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The above information combined with the previously submitted information contained in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4506.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the 510(k) premarket notification (K060662) demonstrate that the QMT NIMBUS Barrier</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4520.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dressing is most appropriately classified as a Class II device subject to general and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4534.40pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">special controls requiring a 510(k) premarket notification.   The performance testing has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4548.20pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">demonstrated that the device performs as intended and is safely used as a low risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4562.00pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">medical device.  We believe this device should  be classified based on section 513(a)(1)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4575.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the Act using General Controls (Establishment Registration, Device Listing and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4589.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Labeling) and Special Controls (labeling requirements for wound dressings and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4603.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">performance standards such as biocompatibility and antimicrobial testing).  The risk-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4617.15pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">based classification that is most appropriate for the QMT NIMBUS Wound Dressing is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4630.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Class II subject to the above named general and special controls as well as the 510(k)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4644.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">requirements and the design controls provisions of the Quality Systems Regulation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:90.00pt;top:4658.50pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">(QSR).</FONT></FONT></FONT></SPAN>
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