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Q: How are surgical masks made? ( Answered 4 out of 5 stars,   0 Comments )
Question  
Subject: How are surgical masks made?
Category: Business and Money > Small Businesses
Asked by: drelp-ga
List Price: $60.00
Posted: 14 Jan 2006 10:49 PST
Expires: 13 Feb 2006 10:49 PST
Question ID: 433367
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  
Subject: Re: How are surgical masks made?
Answered By: crabcakes-ga on 14 Jan 2006 14:42 PST
Rated:4 out of 5 stars
 
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
drelp-ga rated this answer:4 out of 5 stars

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