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Intended to be worn by operating room personnel to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material.

These disposable surgical masks are formed of three layers and are flat-fold disposable face masks comprised of two segments which form a comfortable mask covering the nose and mouth areas of the face. The outer mask surface is of non-woven polypropylene. The middle layer, between the non-woven outer and inner lavers, is made of "meltblown" air filtration media. This material is designed as a highly efficient bacterial filter with very low pressure drop, to facilitate breathing and minimize spectacle fogging. The facial layer is of non-woven polypropylene. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing. Drawings of the Defend Surgical Mask appear in Attachment I. These are intended to be exemplary rather than exhaustive. The mask is formed of three layers and is a flat-fold disposable face mask comprised of pleated segments which open to form a comfortable mask covering the nose and mouth areas of the face. The sides are secured by binding tapes to which is attached the elastic band to secure the mask to the face. The top and bottom of the mask are fused to prevent fabric delamination. The outer mask surface is of Spunbond non-woven polypropylene (20 g/m'). The middle layer, between the non-woven outer and inner layers, is made of meltblown air filtration media. The characteristics of this media are listed in Attachment VI, This material is designed as a highly efficient bacterial filter with very low pressure drop, to facilitate breathing and minimize spectacle fogging. The facial layer is of Thermobond non-woven polypropylene (15 g/m²). The characteristics of the two outer layers are also listed in Arachment VI. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing. The mask has a light aluminum strip which bends readily to fit closely over the nose, diminishing fogging of spectacles. It also has a light foam strip fused to this edge to provide more effective coverage and user comfort. Two woven elastic ear loops complete the mask. The products will be sold non-sterile, prepackaged, and are disposable, for single use only.

to act as physical barrier including fluidresistant properties, provide only very low impediment to breathing, avoid fogging of surgeons glasses, effective filtration of particles, droplets, not hinder speech. These are the same as those of the predicate devices These products also have the same intended yses as similar products currently cleared for marketing by the 510(k) process

These disposable surgical masks are formed of three layers and are flat-fold disposable face masks comprised of two arcuale segments which form a comfortable mask covering the nose and mouth areas of the face The outer mask surface is of non-woven polypropylene The middle layer, between the non-woven outer and inner layers, is made of "Web Dynamics" air filtration media. This material is designed as a highly efficient bacterial filter with very low pressure drop, to faciliate breathing and minimize spectacle fogging. The facial layer is of non-woven polypropylene. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing