What are prosthetic masks made of and how are they manufactured?

How are surgical masks made?

• I have a 3 part question regarding the manufacture of surgical masks. How are surgical masks made? Walk me through the process from start to finish - starting point of raw materials, how the mask is formed, why are they usually blue (are any chemicals put into the fabric?) etc. What makes a mask medical grade (i.e., can be used in a hospital)? Are there special regulations around this? If so, what are they? Sometimes masks have a design put on them (flowers, characters, etc.) - how is this done? Finally, a list of manufacturers US and elsewhere that have the capability to make medical grade surgical masks. Thanks!

• Answer:

  Hello Drelp, There are numerous types of masks ? surgical, respiratory, face masks, and variations of these. I?ve tried to include some information on all types. If any part of my answer is unclear, please request an Answer Clarification, and allow me to assist you further, before you rate this answer. I will be happy to assist you further, before you rate my answer. Actually, your question contains 4 parts! 1) How are surgical masks made? Walk me through the process from start to finish - starting point of raw materials, how the mask is formed, why are they usually blue (are any chemicals put into the fabric?) etc. ======================================================================= Here?s how one kind is made: ?A disposable, foldable face mask with face seal characteristics consistent with the use of high efficiency filtering media. The mask is made of a single multi-layer, generally rectangular sheet of filter material, and at least one of an outer facing layer and an inner facing layer may include a binder to impart stiffness. The generally rectangular sheet has a generally straight top edge, a pair of generally straight side edges shorter than the top edge and defining respective top corners with the top edge, and a bottom edge. Midway between the side edges a fold line extends perpendicularly from the top edge to a termination point. The bottom edge has a configuration which is symmetrical on either side of the fold line, and includes a pair of side portions which define respective bottom corners with the side edges. The sheet is laterally folded on the fold line. On either side of the fold line bottom edge portions are joined such that a mask body is formed. The mask body is essentially flat for storage and, when unfolded, has an opening defined by the sheet top and side edges and sized to cover the nose and mouth of a wearer. Attached to the inside surface of the sheet with reference to the opening adjacent the edges defining the opening is a "tacky" foam sealing strip which slightly adheres to the face of the wearer. Alternatively "tacky" tape which slightly adheres to the face of the wearer may be employed.? http://www.freepatentsonline.com/5735270.html Illustrations and specs here: http://www.freepatentsonline.com/5735270.pdf ?In the preferred or first embodiment, the liquid-resistant disposable face mask has a three-layered laminate structure that is pleated and sized to cover the wearer's nose and mouth. The innermost layer (the first ply) which comes in contact with the wearer's face is made of non-woven, airlaid paper material that is liquid resistant and is designed to be soft to the wearer's face and prevent facial hair, perspiration, and saliva from exiting the face mask. The second layer is the middle section of the face mask and is made of non-woven, liquid-resistant, meltblown, polypropylene material which is designed to act as a filter media barrier against bacteria, body fluids, and particulate contaminants. The outermost layer (the third ply) of the face mask is made of non-woven, liquid-resistant, thermobond, polypropylene material which is designed to be the first contact filter barrier layer against body fluids and liquid particulate contaminants from outside of the wearer's face mask. The face mask's three-ply laminate structure is made into a single entity by the use of an ultrasonic heat-sealing machine, which heat seals the perimeter edges of the three-ply laminate composite structure. The face mask is secured to the wearer's head and face by either ear loops or head ties. In an alternate or second embodiment, the liquid-resistant, disposable face mask has a four-layered laminate structure that is sized and pleated to cover the wearer's nose and mouth. The innermost layer (the first ply) which comes in contact with the wearer's face is made of non-woven, colored spunbond, polypropylene material that is designed to be soft to the wearer's face and act as an initial barrier to liquid and particulate matter for the wearer of the mask. The second layer is made of a non-woven, liquid-resistant, airlaid paper material and is designed to act as a liquid barrier. The third layer is made of a non-woven, liquid-resistant, meltblown, polypropylene material which is designed to act as a filter media barrier against bacteria, body fluids, and particulate contaminants. The outermost layer (the fourth ply) of the fact mask is made of non-woven, liquid-resistant, thermobond, polypropylene material which is designed to be the first contact filter barrier layer against body fluids and liquid particulate contaminants from outside of the wearer's face mask.? http://www.freepatentsonline.com/5467765.pdf ?ValuMaxR Surgical Masks are pleated 3-ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% tneltblown polypropylene filter media. Ear-loops are made of soft latex free elastic loops. The nose piece for all ValuMax" Face Masks is malleable aluminum wire. Fog free masks have an anti-fog strip. Masks with splash visors have anti-fog treated plastic shield attached to masks, All of the material used in the construction of the ValuMaxR Surgical Masks are being used in currently marketed devices (see predicate information).? ?Discussion of Non-Clinical Tests Performed for Dertermination of Substantial Equivalent are as Follows: a. Bacterial Filtration Efficiency (BFE) b. Pressure Differential (Delta P) c. Latex Particle Challenge (PFE) d. Flammability e. Biocompatibility per ISO 10933 f. Fluid Resistant - Synthetic Blood Penetration Resistant Test There are also addresses of manufacturers on this document. http://www.fda.gov/cdrh/pdf4/k040333.pdf ?Pleated facemasks for a high level of protection and comfort. Made of 100% polypropylene with glass-free filter media; Fluid-resistant design; Lightweight, cool and breathable? http://www.websoft-solutions.net/Surgical_Masks_Surgical_Face_Masks_p/disposable-surgical-face-mask.htm This article on clear face masks, currently patented by Kimberly Clark may interest you. http://www.amphl.org/jamphl/fall2002/cordwellcarroll.html Same article, different format. http://www.amphl.org/jamphl/fall2002/cordwellcarroll2002.pdf As to why the masks were blue, I found no documented information. Blues and greens were selected for hospitals and dentists, as they are considered calming and soothing colors. When I began working in hospitals in 1972, all scrubs were green, and all masks were blue. Today the masks come in various colors,as do scrubs, though I can?t find printed masks. Some hospitals like to assign certain colors to specific areas of the hospital, for style (?) and simplicity of materials management. For example the maternity department might select pink, and the nursery may select yellow. As you can see by looking at the links, the same type of mask comes in various colors, there are no chemicals. Perhaps blue was cheapest years ago! 2) What makes a mask medical grade (i.e., can be used in a hospital)? Are there special regulations around this? If so, what are they? ======================================================================= ?INTENDED USE: This product meets CDC guidelines for Mycobacterium tuberculosis exposure control. As a respirator, it is intended to reduce wearer exposure to certain airborne particles in a size range of 0.1 to >10.0 microns, including those generated by electrocautery, laser surgery, and other powered medical instruments. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials; when worn properly and in combination with protective eyewear, it complies with the OSHA Bloodborne Pathogens Standard. It also provides >99% BFE2 against wearer generated micro-organisms.? http://www.surgical-face-masks.co.uk/images/3m-1860-n95-respirator-masks.pdf ??As a manufacturer of face masks, we have an obligation to the end user to manufacture our masks with high-quality materials that meet and/or exceed the standards established within the healthcare industry,? says Andrew Whitehead, vice president of sales and marketing at Crosstex International. ?The current standards are found in ASTM F-2100-04 and are called ?Standard Specification for Performance of Materials Used in Medical Face Masks.? In the past few months, we have seen literature, ads and packaging that reflect the statement ?meets ASTM Standards.? While this is a positive, the problem is that within the standard, there are three performance class specifications ? low barrier, moderate barrier, and high barrier ? which very few people are talking about.? Whitehead continues, ?Each represents a different level of protection relative to fluid resistance. If someone is doing a basic exam with little or no exposure to fluid, then the low barrier is fine. However, if someone is involved in a procedure that has a large potential for blood, aerosols, and/or moisture, then they should be wearing a mask that meets the high barrier performance class specification. The manufacturer should clearly identify which masks meet which performance level. It is the wearer?s job to identify the appropriate mask for the procedure they are performing.? N-95 ?For workers who are dealing directly with infectious disease such as influenza, the CDC recommends an N-95 (or higher) face mask with a good tight fit around the edge where it contacts the face. These can be difficult to tolerate for long periods because they make breathing harder. They are more expensive than procedure masks.? Fluid Resistant ?Fluid Resistant Surgical Mask: Not optimal but not a good second choice. These are not recommended for those working with patients infected with flu. They do offer some protection and are more comfortable and less expensive. High performance surgical masks exceed 99% filtration efficiency at 0.1 microns. Again, fit is important with airborne disease.? http://www.n-95mask.com/avian_flu_mask.html ?All masks are useless unless they fit well. Air takes the path of least resistance and bypasses the mask if there?s a gap. One mask, the N-95 or dust mask, filters out 95 % of particles that are 0.3 microns across or larger. So the N-95 might protect you from a SARS victim?s sneeze if it fits tightly. However, the SARS virus may be 0.1 micron across; flu viruses are about 0.2 microns.? Dust mask ?Not to be relied upon are simple dust masks and procedure masks not meeting these fluid resistant and filtration standards. Here, we see a procedure mask that would be fine for blood splatter and blood borne pathogen protection (hepatitis B and HIV) but it is not fluid resistant and not effective enough to filter small airborne viruses like flu. Also shown is a simple dust mask used for construction and sanding and not a wise choice for infectious disease.? http://www.wonderquest.com/sars-mask.htm ?Surgical Masks Standard surgical masks provide filtration of particles larger than 5 microns. This is not satisfactory considering the majority of the particulate in surgical smoke contains particles smaller than 1.1 microns. Originally, surgical masks were designed for patient protection, ensuring that healthcare worker?s oral, nasal, and respiratory particles and bacteria did not infect the patient during procedures. These masks were not created with the intention for capturing dangerous gases and viruses created during tissue ablation with thermal tools. However, it is still important to utilize these tools to protect against particles larger than 5 micron found in surgical smoke plume. Ensure masks fit properly and 2 do not have any air flow around the perimeter of the mask.? http://www.buffalofilter.com/PDFFiles/CEUBuffaloFilter.pdf ?SURGICAL MASKS Fluid resistance surgical mask: ? Layers: 4-ply ? Filter: 25gsm meltblown filter, MediGrid filter ? Colour: orange ? Optional: anti-fog visors Sub-micron surgical mask: ? Layers: 3-ply ? Filter: 25gsm meltblown filter ? Colours: blue, green, white, pink and yellow ? Optional: anti-fog visors General purpose surgical masks: ? Layers: 3-ply ? Filter: 20gsm meltblown filter ? Colour: blue, green, white, pink and yellow http://www.hospitalmanagement.net/contractors/disposables/creative/ ?Question: Some people are starting to wear homemade cloth masks in the OR. The same masks are worn all day. Is this acceptable? What argument can be made against this practice? Answer: Homemade cloth masks are unacceptable. Although early masks were made of muslin or linen, they only redirected exhaled air away from the surgical wound. Cloth surgical masks were replaced in the early 1960s with synthetic materials that also provide bacterial filtration.3 Wearing masks is recommended for two reasons. First, they contain and filter microorganism droplets that are expelled from the mouth and nasopharynx during talking, sneezing, and coughing. Second, they protect the wearer from exposure to infectious materials and other respiratory hazards, such as electrosurgical and laser smoke.4 Fluid-resistant surgical masks are considered personal protective equipment (PPE), and the Occupational Safety and Health Administration requires health care workers exposed to blood and other body fluids to wear them. To be considered appropriate, PPE must not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.5 Surgical masks should filter at least 0.3 µ of bacteria for regular use and 0.1 µ for laser use, or they should provide 90% to 95% bacterial filtration efficiency.6 Masks must be changed between uses and whenever they become moist. Masks should not be reused throughout the day or saved by hanging them around the neck or tucking them into a pocket for future use.7 The filter portion of the mask harbors bacteria collected from the nasopharyngeal airway, and care must be taken when removing the mask to avoid contamination of the hands. It is extremely unlikely that an individual would have an adequate supply of freshly laundered--not home laundered--reusable masks to be able to change as frequently as recommended. Although there may be reusable materials that could meet fluid resistance and filtration criteria, it is extremely unlikely that a suitable reusable cloth material could be found, tested by an individual according to US Food and Drug Administration (FDA) guidelines, and manufactured on a home sewing machine according to industry specifications. Surgical masks are an FDA class II medical device that require special controls and are subject to premarket notification procedures (ie, 510k guidelines).? http://www.aorn.org/journal/2001/julyci.htm#mask See all pages: http://www.msf.org/source/refbooks/msf_docs/en/Catalog/E/LIN/ELINMASS1--.pdf OSHA regulations http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=PREAMBLES&p_id=811 http://www.fda.gov/cdrh/ppe/masksrespirators.html#6 3) Sometimes masks have a design put on them (flowers, characters, etc.) - how is this done? ======================================================================= Surgical masks are not generally imprinted with flowers or cartoons. I have never seen them, though they may exist.(I could find none online) Some face masks for children that need some extra protection may exist, but they are not surgical quality. Here are some imprinted non-medical grade masks: http://www.breathehealthy.net/ 4) Finally, a list of manufacturers US and elsewhere that have the capability to make medical grade surgical masks. ======================================================================= Here are sites of mask manufacturers: AMD Ritmed http://www.amdritmed.com/ http://www.amdritmed.com/PersonalHome.htm# BL Life http://www.blmarket.com/manufacturing.html http://www.blmarket.com/surgical-gowns-masks.html#masks Omnical http://www.omnical.com/ http://www.omnical.com/face.htm DelStar Technologies http://www.thomasregister.com/olc/45420007/p-delpor.htm Dispowear Sterite http://www.indiamart.com/dispowear-sterite/ Irema http://www.irema.com/SurgicalMasks.asp Respiratory Masks http://www.irema.com/RespiratorMasks.asp Horman Company http://www.manufacturers.com.tw/showroom-6467-3-1-0-3858.php Guangzhou http://www.manufacturers.com.tw/showroom-6477-3-1-0-3858.php Diling Medical Instruments http://dilingchina.en.ec21.com/company_info.html http://dilingchina.en.ec21.com/GC00842058/CA00842074/Non-woven_Products.html Medi Plus, India http://www.mediplusindia.com/miscellaneous2.htm J International CityM Korea Co., Ltd http://feeljune.en.ec21.com/company_info.html http://feeljune.en.ec21.com/GC01088486/CA01088570/Nano_Silver_Mask.html Waves, India http://www.indiatoothbrush.com/mask.html Parkson http://www.manufacturers.com.tw/showroom-665-1-1-0-3858.php Ahlstrom http://www.hospitalmanagement.net/contractors/clothing/nonwoven/ Find numerous mask manufacturers and specs on masks on the FDA site: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm Hope this helps you out! Again, please utilize the Answer Clarification process, to ensure you get the answer you need, before rating! Sincerely, Crabcakes Search Terms ============ surgical masks + standards + microns surgical mask + manufacturers how surgical masks are manufactured manufacture + process + surgical masks disposable face masks + how made significance of surgical mask color