FORM- 2
THE PATENTS ACT, 1970 (39 OF 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. Title of the Invention: "A FOLDABLE SURGICAL GOWN WITH IMPERMEABILITY
CORRESPONDING TO OPEN SURGERY STANDARD"
2. Applicant(s): JOHNSON & JOHNSON LTD.
Name, Nationality & 30, Forjett Street,
Address Mumbai 400 036
INDIA., an Indian Company
3. Preamble to the
Description
PROVISIONAL the following specification describes the invention
COMPLETE : The following specification particularly describes the
invention and the manner in which it is to be performed

FIELD OF INVENTION
The present invention generally relates to a disposable surgical gown worn by surgeons during operation procedures. More particularly, the invention relates to a foldable surgical gown with impermeability corresponding to open surgery standard.
BACKGROUND OF THE INVENTION
Generally, surgeons and other medical professionals will wear an overgarment during operating procedures both to enhance the sterile condition in the operating room and to protect them from blood and airborne pathogens. The overgarment is typically configured as a gown having a main body portion to which respective sleeves are attached. The gowns are often made from a breathable nonwoven barrier material and are intended to be disposable.
Medical gowns are typically closed with ties. The gowns are open at the back and a tie is provided across the two back panels of the gown at the waist. Ties may also be provided inside the gown at the waist (similar to the inside button of a double-breasted suit) and at the neck. To avoid having the ties touch a nonsterile hands, they are attached to a transfer card which is used by an assistant to knot the ties. This arrangement ensures sterility of the gown is maintained, though the assistant need not be sterile.
A medical gown is known from US Patent Number US 6138278, which comprises a main body covering portion and sleeves extending from the body portion. The

body portion has an opening for donning the gown and at least one closure for closing the opening. The closure comprises an adhesive on a first side of the opening and a region on the second side of the opening to which the adhesive attaches to close said opening.
Preferably, the body covering portion is formed of a nonwoven fabric. The adhesive may be printed directly onto the gown fabric on the first side, may comprise a piece of double-sided tape affixed to the first side, or other suitable method.
When the gown in sterile, the adhesive can be located on the first side of an attachment portion of the gown with a removable member on a second side of the attachment portion. Thus a non-sterile hand may press against the removable member to adhere the adhesive to the second side and then remove the removable member leaving a wholly sterile gown. The removable member can comprise a release member removably placed over the adhesive.
The closure may further comprise a removable member adjacent to the opening for manipulating the closure into position for adhering the adhering and the gown, whereby a nonsterile hand may place closure in such position and then remove the removable means to leave a sterile closed gown.
AATCC Test Method 127-1989 measures the resistance of fabrics to the penetration of water under static pressure, with the water column being measured in centimeters. Test specimens are mounted under the orifice of a conical well and are subjected to water pressure increasing at a constant rate (1 cm/sec) until three points of leakage occur through the fabric. The ASTM Emergency Standard 21 and 22 define imperviousness for medical gowns. One side of a test sample of fabric is exposed to synthetic blood medium (with a bacteriaphage for method 22).

Pressure is applied across the test sample of the fabric on the following schedule: 5 minutes at atmospheric pressure (on both sides of the fabric), one minute with 2 psi applied to the fluid side of the fabric, the other side remaining at atmospheric pressure, followed by 54 minutes with both sides at atmospheric pressure.
According to AAMI Barrier Performance Classification, the surgical gown can be categorised as under based on level of exposure risk:-

ANSI/AAMI Fluid Fluid Spray Pressure on Examples of Procedures with
PB70 Barrier Amount or Splash Gown or Anticipated Exposure Risks
Performance Drape
Level 1 Minimal Minimal Minimal • Simple/excision Excision of
"lumps and bumps"
biopsies" Ophthalmological
procedures
• Simple eye, nose and throat
(ENT) procedures
Level 2 Low Low Low Tonsillectomies and adenoidectomies Endoscopic gastrointestinal procedures Simple orthopedic procedures with tourniquets. Open hernia repair Minimally invasive surgery Interventional radiology/catheter lab procedures.
Level 3 Moderate Moderate Moderate Mastectomies Arthroscopic orthopedic procedures Endoscopic urological procedures (e.g., transurethral prostate resections) Open gastrointestinal and genitor-urinary procedures
Level 4 High High
High Any procedure in which the surgeon's Orthopedic procedures without a tourniquet Open cardiovascular/thoracic procedures Trauma procedures Caesarean section

Surgical gowns of this type are often packaged and presented to the wearer in a "book-fold" arrangement. In such an arrangement, exterior surfaces of the gown are contained largely inside the folded garment. Hand pockets are located on each side of the folded garment for receipt of the wearer's respective hands. As the hands are lifted up and out, the gown will unfold and fall into place on the wearer's body.
It is further known in the art the technique of folding the surgical gown in which each flap is turned at least partially back upon itself to expose an interior surface of the main gown. The sleeves are each folded behind the back portion of the main gown. The main gown is also back folded along first and second longitudinal fold lines extending substantially parallel to the lateral sides thereof. In addition, the main gown is back folded after folding along the longitudinal fold lines along at least one transverse fold line substantially transverse to the lateral sides of the main gown to define left and right hand pockets. The main gown is further folded along a third longitudinal fold line to form a folded surgical gown such that respective hand pockets are located on opposite sides thereof.
Ultrasonic stitching technique is known which replaces the traditional needles and thread, and/or adhesive for enjoining two or more different components/pieces. Such technique is known to be adapted in packaging, knitting products, surgery mask, bed covers, and others. According to the known technique of ultrasonic fabric stitching technique, a high frequency sonic wave is transmitted by an ultrasonic fabric sewing machine which causes the molecules at the joinable edge of the fabric to reach at plastic melting point. Further, high frequency oscillation of the stitching head of the machine, leads to continued transmission of sonic wave completing dissolution of the solid material and ensure an absolute leak-free sealing of two or more joinable pieces provided

their edge preparation is in registration. This technique is also adaptable to three-dimensional surfaces for ultrasonically conjoined. The additional advantage of this technique is that, the finsional sealing eliminates any preheating, and there is no development of crack on the sealed edges, and the joinable pieces are sealed without any damage to the fabric edges including any occurrence of curling phenomenon.
Surgical gowns have for many years been manufactured with hydroentangled nonwovens. Hydroentangled nonwovens are made from a mix of pulp fibers and synthetic fibers. A cuff of stitched cotton is usually positioned in the low end of the sleeve for comfort and to keep the gown in place and facilitate sterile donning of the surgical gloves.
In recent years, other nonwoven materials have been introduced as alternatives to hydroentangled nonwovens, which constitutes several layers of fibrous webs where an inner layer is placed between layers of spunbond fibers. The most common polymers used are polypropylene.
OBJECTS OF INVENTION
It is therefore an object of the invention to propose a foldable surgical gown with impermeability corresponding to open surgery standard.
Another object of the invention is to propose a foldable surgical gown with impermeability corresponding to open surgery standard, which is formed of a single piece 50 gsm spunbond and melt blown composite fabric.
A still another object of the invention is to propose a foldable surgical gown with impermeability corresponding to open surgery standard, which is enabled to

maintain its sterility till unfolded in the Operation Theater.
SUMMARY OF INVENTION
Accordingly, in a first aspect of the invention, there is provided a foldable surgical gown with impermeability corresponding to open surgery standard comprising a main body configured to cover a predetermined location of a wearer's physic, the main body having a front portion and a rear portion formed out of a single sheet produced from 50 gsm spunbound and melt blown composite fibre, the rear portion provided with an opening including at least two pairs of ribbons acting as waist closure; left and right sleeves produced from a fabric identical to that of the main body and attached to said main body to substantially extend from an upper neck portion of the body upto the bottom edges, the sleeves configured with a slanted edge with dual panel corresponding to the attachable edge of the main body to allow an anti tug motion to the wearer performing the open surgery, wherein the first panel of the sleeves extending across the front shoulder to arm pit is ultrasonically fused, wherein the second sleeve panel extending a cross the back shoulder rearwardly upto the armpit is glued or stitched, and wherein the ultrasonic fusing process comprising a plurality of tiers forming a fail-safe protective closure in which a first tier produced with a dotted line closure at a first level repelling about half of fluid generated during the surgical intervention, and a second tier formed of a solid line closure providing final level of protection to repel the remainder of the fluid-content wherein the pairs of waist closure is either glued or stitched or ultrasonically fused to the rear portion of the main body to provide the desired level of protection to the wearer, and wherein the surgical gown is foldable to maintain the desired sterility till opened for wearing by the surgeon.

In a second aspect of the invention, there is provided a foldable surgical gown with impermeability corresponding to open surgery standard comprising, a main body formed of a single sheet of 50 gsm spunbond and melt blown fabric, having a front portion and a rear portion, the rear portion provided with an opening including at least one waist closure; a pair of sleeves having slanted edges consisting of at least two panels attached adjacent to the neck on two sides of the main body, the front body portion and the sleeves each constitutes a critical zone, the rear portion of the main body including the waist closure constitutes a non-critical zone, wherein the first panel of the sleeves are attached to the upper shoulder extending to the arm pit of the main body by application of ultrasonic sealing procedure, the second panel of the sleeves extending backwardly to the rear portion of the body is glued or stitched, the ultrasonic seam portion comprises at least two dotted line closures provide a first level of protection allowing a minimum fluid flow , and at least two solid line closures provide a final level of protection disallowing any flow-through of the generated fluid during the process of surgical intervention.
According to a third aspect of the invention, there is provided a method of folding a surgical gown with impermeability corresponding to an open heart surgery standard, the surgical gown having a main body with an opening at rear portion and made of a single piece fabric constituting 50 gsm spunbond and melt blown composite fiber, to which respective left and right sleeves are attached through an ultrasonic sealing pattern, the method comprising the steps of folding left and right flaps of the main body at least partially back upon one another to expose a shiny interior surface of the main body; folding said left and right sleeves behind the rear portion of said main body; folding back said main body along two parallel axial fold lines through the corresponding lateral sides; folding back the main body along at least one transverse fold line extending parallel to the lateral sides to define at least one waist closure after folding said lateral sides; folding said waist closure to keep those horizontally and adjacently placed;

and folding said main body along a third axial line to form a folded surgical gown.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
Figure 1A - is a front elevational view of a foldable surgical gown with higher impermeability according to the invention
Figure IB - is a rear elevational view of Figure-1
Figure 2 - shows construction of a packaging material adapted to produce the surgical gown of Fig-1.
Figure 3 - shows a front view of the surgical gown of the invention illustrating the critical zones.
Figure 4 - shows six different patterns of ultrasonic sealing closures employed to produce the surgical gown of the invention.
Figure 5 - shows a configuration of the sleeves and cuffs with a combination of stitches and ultrasonic fusing of the surgical gown of the invention.
Figures 6A -6F - shows the folding arrangement of the surgical gown of the invention when viewed from the front.
Figures 6A' to 6D' - shows the folding arrangement of the surgical gown of the invention when viewed from the rear.

DETAIL DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION
Figures 1A and IB illustrate surgical gown (SG) according to the present invention. It comprises a body (B) having a front portion (BF) and back portion (BB) and a pair of sleeves (SL). The body (B) and sleeves (SL) are formed of a spunbond/ meltblown composite (SMS) fabric to provide a disposable gown. As shown in fig-2 SMS is generally made of various alternating layers of spunbond and melt blown webs : SMS, SMMS, SSMMS, etc. SMS is a combination of two spunmelt technologies: Spunbond-outer layers and Meltblown-inner layer (several layers or beams).
SMS structure variations (SMS, SMMS, SSMMS) are a consequence of desired properties and economics to achieve them. Both meltblown and spunbond as the name indicates are processed through melting the polymers, spinning and bonding. Spunbond layers are continuous fibers with fiber size between 10 and 20 microns typically. Meltblown layers are continuous fibers with averages sizes varying between 2 and 3 microns. Spunbond layers provide strength and meltblown layers provide barrier.
A chest area (CA) and sleeve areas (SA) both configured with dual-panel matching edges. The chest area (CA) extends up to a neck (N). The gown (SG) of Fig. 1 is shown in an open configuration prior to being donned by a wearer and it would be expected that when so donned the body back (BB) area provided with ribbons/fastener (RB/FS) shall hold the gown on the user. The sleeve (SL) extend from a cuff (C) up toward the shoulder seam where the sleeves (SL) join the gown body (B).
The packaging material adapted to produce the surgical gown (SG) constitutes an improved material compared to other known porous packaging material-even

under the most rigorous conditions. Further, a long-term shelf-life study exhibits a superior tear strength and puncture resistance of the packaging material.
The tough and continuous fibers of the packaging material protects the package integrity from both product breakthrough Inside and rough handling outside, ft resists punctures-even from the irregular or sharp edges of many surgical devices.
Because the structure of the packaging material used for packing the inventive surgical gown (SG) makes it low-linting, virtually disallowing generating any airborne particles when the packages are opened. This clean peel minimizes the risk of introducing particulates into a clean environment.
The packaging material used for the surgical gown (SG) is compatible with all the commonly used sterilization methods. Whatever the sterilization process for example, ethylene oxide (EtO), gamma, electron-beam, steam (under controlled conditions) or newer methods, such as the Sterrad® Sterilization System is used to sterilize the gown, the packaging material adapted according to the invention is enabled to maintain sterility of the gown, the properties, color and flexibility of the packaging material.
The process of manufacturing the packaging material adaptable to the invention allows the sheet to be subjected to airborne particulates and microbes for a shorter period of time, making the bioburden on the surface of the material very low. This low bioburden does not add significantly to the required sterilization time. Measured as colony forming units (cfu) per ft2, the typical bioburden of the packaging material is 62. For other known packaging material the bioburden rate is 93; and 80.

The packaging material adapted to produce the inventive surgical gown is made of 100 percent high-density polyethylene, which offers the best combination characteristics of paper, film and fabric in one material. This unique balance of properties, which cannot be found in any other material, makes the packaging material lightweight yet strong; vapor-permeable, yet water-and chemical resistant; as well as puncture-, tear-and abrasion resistant. The packaging material is further low-linting, smooth and opaque. Table 1 lists specification and other properties of the packaging material adapted for producing the surgical gown of the invention.
Additionally, the packaging material is produced by a fully integrated process using continuous and very fine fibers (having an average diameter of 4 micrometers) of 100 percent high density polyethylene that are randomly distributed and non directional. (For purposes of comparison, a human hair is approximately 75 micrometers in cross section). These fibers are first flashpun, then laid as a web on a moving belt before being bonded together using only heat and pressure. By varying both the lay-down speed and the bonding conditions, the fabric can be flush-spanned to produce sheets with soft and hard structure. The soft structure is designed specifically for applications where drape, hand and soft feel are of prime importance, such as limited-use protective garment. The hard structure sheets can supplement the traditional paper by offering superior tear-resistance and lighter weight.
Table I. Specification and other properties of the protective material used for producing the surgical gown.
Property Comparable Units the fabric of the invention
Test Method

SPECIFICATION PROPERTIES*
Basis Weight * ASTM D3776'
DIN EN ISO 536' oz/yd2 (9/m2) 1.76 (59.5)
Delamination* Gurley Hill ASTM D27242 TAPPIT46010 lb/in
(N/2.54cm) sec/100 cc 0.61 (2.7) 22
Porosity* ISO 5636-5
OTHER PROPERTIES
bendtsen Air Permeability ISO 5636 mL/mn
520
Hydrostatic Head AAATCC TM DIN EN 208114 127in. H20 (cm H20) 57 (145)
Tensile Strength, MD ASTM D50355 DIN EN ISO 1924-25 lb/in (N/2.54 cm) 35.1 (156)
Tensile Strength, CD ASTM D50355 DIN EN ISO 1924-25 lb/in (N/2.54 cm) 35.3 (157)
Elmendorf Tear, MD ASTM D1424 DIN EN 21974 1b
(mN) 0.63 (2.8)
Elmendorf Tear, CD ASTM D1424 DIN EN 21974 1b (mN) 0.83 (3.7)
Mullen Burst ASTM D774 ISO 2758 psi (kPa) 134 (925)
Thickness ASTM D17775 DIN EN 205347 mils (μm) 6.11 (155)
Opacity TAPPI T425D ISO 24718 % 94.3
MISCELLANEOUS PROPERTIES
Microbial Barrier ASTM F1608 Log Reduction Value (LRV) 3.2

Elongation, CD ASTM D50355 DIN EN ISO 1924-25 % 23
Thickness Range ASTM D17776 DIN EN 205347 mils (4 sigma) (Mm) (4 sigma) 2.8-9.1 70-230
Spencer Puncture ASTM D34509 in-lb/in2 (J/m2) 28 (4900)
The gown construction involves a novel and inventive features, namely:
The gown (SG) is stitched from a single piece of fabric with only the sleeves (SL) attached to the body (B). This single fabric construction ensures minimal stitching/fusing and hence exhibits higher impermeability.
The sleeve seams constituting the first panel and matching with that of the front body portion are fused to the fabric using ultrasonic technology, making the gown to meet Level 3 standards of impermeability. The second panel of the sleeve and the matching rear body portion of the gown is glued or stitched. The ribbons are stitched or glued to the rear body portion of the gown through patches provided thereon. The waist-closure constituting the ribbons and stitches may alternatively be ultrasonically fused.
Te ultrasonic fusion follows a solid and dotted line pattern (SLC, DLC-I) making the gown (SG) to meet Level 3 standards of impermeability. Ribbons/fasteners (RB1, Rb2) are located in the back portion (BB) of the gown (SG), which is considered a non-critical zone. This again ensures that there is minimal chance of fluid permeability-

The edges of the sleeves (SL) are configured with a slanted cut with dual-panel which allows an anti-tug extended motion to the surgeon. This especially useful when operating in areas on the patient's anatomy difficult to reach. This configuration allows the surgeon a more comfortable and ergonomic range of movement.
To further maintain the sterility of the gown (SG), a paper card is attached to the ribbons (RB1, RB2) which the OR assistant can use to hold the gown (SG) while helping the surgeon to wear the gown (SG). This card enables the assistant to tie the ribbons (RBi, RB2) around the surgeon's girth. In addition, the card has serrations to allow "easy peel-off" thereby leading to ease of wearing the gown (SGO without compromising on the sterility.
It is not only necessary that the gown (SG) is made Level 3 standards but it is also equally important to maintain its sterility until it is opened in the OR for adornment by the wearer. In order to provide a solution to this requirement, the packaging material plays a significant role. The inventive surgical gown (SG) is packed on one side with a puncture-resistant material which further ensures impermeability. The packaging material constitutes a clear see-through plastic sheet which additionally acts as an impermeable barrier.
The gown is provided with two towels detachably attachable for the surgeon to wipe hands dry after scrubbing.
The ultrasonic fusion can take many forms. The most preferred embodiment of the invention imbibe continuous and broken line pattern as shown in fig-4. However, there are other possible patterns that can be used to achieve level 3 protection. These patterns (2,3,4,5,6) are illustrated and shown in fig-4.

Further, ultrasonic fusion meet the following requirements:
Frequency : 20KHZ, Output power: 1400W, speed 0-18m/min, electric source:220ACIP
roller spec: 51 (Dia), 18mm (W).
Fig-IB shows the back of the gown (SG) having a pair of waist closure 5. The gown (SG) has an opening (OP) in the back (BB). A first edge and second edge of the waist closure are connected to each other to effect closure.
Figure 3 above illustrates critical zones in a surgical gown (SG). The body front portion depicted by (CA) and the sleeve area depicted by (SA) constitute the zones in the surgical gown (SG). The inventive surgical gown (SG) is enabled to meet the Level 3 protection in the critical zones (SG, CA).
To achieve level 3 protection in the front portion (CA), the gown (SG) is stitched from a single piece of SMS fabric that passes \eve\ 3 requirements. Further, the SMS fabric patches (FP) are added over the ultrasonic joints where the ribbons (RB1, RB2) are attached to the gown (SG), to ensure a Level 3 protection.
The sleeve (SL) is attached separately to the body (B) made of a single piece fabric. To achieve the Level 3 protection at the critical sleeve area (SA), ultrasonic sealing is employed along the seam adjoining the first panel of the sleeve and that of the front body portion of the gown. The uniqueness of the ultrasonic sealing employed in the gown (SG) resides in the pattern adapted for sealing. One of the six patterns (1, 2, 3, 4,5,6) illustrated in Fig 4, can be adapted for the ultrasonic stitching of the body (B) and the sleeves (SL) of the surgical gown (SG). The first pattern (1) has a dotted line closure (DLC-I)

followed by a solid line (SLC) closure. The dotted line closure (DLC-I) provides the first level of protection repelling almost 50% of the fluids at that level. The solid line (SLC) provides a second and final level of protection and repels the remainder of the fluid content. The fluid content escapes through the gaps in the dotted line (DLC-I) closure at upper the level. This arrangement ensures the Level 3 protection along the sleeve (SL).
Similarly, the alternating patterns (2,3,4,5,6) of the solid and broken line ultrasonic closures (DLC-I,SLC) can be employed to achieve the Level 3 protection. The broken line closures (DLC-I) ensures minimal fluid flow to the level below and also act as a vent for the marginal fluid content repelled by the bottom layer to escape. These unique patterns ensure Level 3 protection along the sleeve (SL).
The waist closure has a pass-off feature which achieves an effect similar to pass-off cards used on known surgical gowns with the ribbons (RB1, RB2) at the waist. The ribbons (RB1, RB2) are attached to a card which is passed by a wearer to an assistant, who need not be sterile, merely clean. The assistant then passes one of the ribbons (RB1, RB2) around the wearer's torso touching only the card. The wearer then grasps the ribbons and the non-sterile ribbons are removed.
The closure comprises a ribbon (RB1, RB2) which is formed of the same material as the gown (SG) and which extends laterally from the first end thereof is joined by stitching or glued to patches (S1, S2) to the second end attachable the side of the gown (SG). A face of the ribbon which faces outwardly bears an adhesive with a release provision. The release provision similarly has a first end and a second end corresponding to the ribbon first and second ends. The release

means first end extends slightly from the adhesive to form a card and the second end and the second end is releasably attached to the ribbon second end.
Figs 6A to 6F show the folding arrangement of the surgical gown when viewed from front. Figs 6A' to 6D1 show the folding arrangement from the rear including eh Velcro (VC5) provided inside the gown including the shiny parts of the single piece fabric used inside the surgical gown (SG).
Preferably, ten steps are performed to complete the folding arrangement of the surgical gown (SG). In exemplary embodiments, the body of the gown is back folded along first and second transverse fold lines after being back folded along the first and second longitudinal fold lines. Preferably, the body of the gown is further back folded along an initial transverse fold line before being back folded along the first and second longitudinal fold lines. For example, the section of the gown body folded along the initial transverse fold line may have a longitudinal length of between one-third and one-half the initial longitudinal length. The resulting longitudinal length may then be folded along the first and second transverse fold lines, thereby yielding a longitudinal length less than the original longitudinal length of the main body. In addition, the sleeves may be folded behind the back portion of the main body of the gown before the main gown is folded along the initial transverse fold line.
The sleeves of the surgical gown are preferably folded behind the back portion of the gown body at an angle from a transverse dimension of the gown body. For example, the sleeves may each be folded in at the lateral sides of the main gown body to completely cross one another behind the back portion of the main gown.

Alternatively, the sleeves may each be folded in at the lateral sides of the gown body and out at an intermediate location thereof back toward the lateral sides.
Various modifications and alterations of this invention will be apparent to those skilled in the art without departing from the scope and spirit of this invention. It should be understood that the invention is not limited to the embodiments disclosed herein, and that the claims should be interpreted as broadly as the prior art allows. For instance those of skill in the art can find suitable alternatives to the specific performance enhancing coatings described herein without undue experimentation.
The packaging material to produce the surgical gown of the invention has been tested under AATCC Test Method 127-ANSI/AAMI PB 70 INDA WSP 80 and ISO 811 on a test piece of 203 x 203 mm. The test results relating to resistance of the material to water penetration under hydrostatic pressure exhibit the following :-
(A) Chest area average failure pressure - 63.12 cm H2O
(B) Sleeve seam average failure pressure - 63.50 cm H2O
A further test has been conducted to evaluate the resistance of the gown material to penetration of water under ANSI/AAMI PB70 standard in a sample piece of 178 x 330 mm with an average flow rate of 21 seconds which exhibit:-
(A) Chest area average amount of penetration - 0.309g
(B) Sleeve seam area average amount of penetration - 0.25g.

WE CLAIM
1. A foldable surgical gown with impermeability corresponding to open surgery standard comprising:
- a main body configured to cover a predetermined location of a wearer's physic, the main body having a front portion and a rear portion formed out of a single sheet produced from 50 gsm spunbound and melt blown composite fibre, the rear portion provided with an opening including at least two pairs of ribbons acting as waist closure;
- left and right sleeves produced from a fabric identical to that of the main body and attached to said main body to substantially extend from an upper neck portion of the body upto the bottom edges, the sleeves configured with a slanted edge with dual panel corresponding to the attachable edge of the main body to allow an anti tug motion to the wearer performing the open surgery, wherein the first panel of the sleeves extending across the front shoulder to arm pit is ultrasonically fused, wherein the second sleeve panel extending a cross the back shoulder rearwardly upto the armpit is glued or stitched, and
- wherein the ultrasonic fusing process comprising a plurality of tiers forming a fail-safe protective closure in which a first tier produced with a dotted line closure at a first level repelling about half of fluid generated during the surgical intervention, and a second tier formed of a solid line closure providing final level of protection to repel the remainder of the fluid-content wherein the pairs of waist closure is either glued or stitched or ultrasonically fused to the rear portion of the main body to provide the desired level of

protection to the wearer, and wherein the surgical gown is foldable to maintain the desired sterility tiff opened for wearing by the surgeon.
2. The surgical gown according to claim 1, wherein the waist closure comprising an adhesive on a first side of the back-opening, and a portion on the second side of the opening to which the adhesive attaches to close said opening.
3. The surgical gown according to claim 1, wherein the gown is sterile, and wherein the gown further comprises a card means on the second side of the ribbon, whereby a non-sterile hand may press against the card member to adhere to the ribbons to the second side and then remove the card means leaving a completely sterile gown.
4. The surgical gown according to claim 3, wherein the card means comprises a releasing provision placed over the adhesive.
5. The surgical gown according claim 1, wherein the ribbon of each side portion is arranged to overlie a part of the opposed side portion.
6. The surgical gown according to claim 5, wherein the ribbon of at least one side portion extends around the wearer's body to the main body when worn by the wearer.
7. The surgical gown according to claim 1, wherein each flap has atleast one respective ribbon disposed at the rear body, the ribbons being ultrasonically stitched on the body and enabled to fasten the gown in use.

8. The surgical gown according to claim 7, wherein each ribbon defines a belt for the gown when fastened in use.
9. The surgical gown according to claim 1, wherein the fabric adapted to produce the gown comprises a high density polyethylene ultra fine fibers having an average diameter of 4-microns.
10.The surgical gown according to claim 1 or 9, wherein the fibers comprises alternating layers of spunbond and melt blown webs. ,
11. The surgical gown according to claims 9 and 10, wherein the fabric has higher puncture resistance and tear strength.
12.The surgical gown according to claims 9 to 11, wherein the bioburden of the fabric is around 62.00 colony forming units per ft2.
13.The surgical gown according to claims 9 to 12, wherein the fabric exhibits a combined characteristic of paper, film, and fabric, and wherein the fabric is lightweight, strong and vapour permeable but impermeable to water and chemical.
14.The surgical gown according to any of the preceding claims, wherein the fabric exhibits a high average hydrostatic failure pressure of 63.12 cm H20 in respect of resistivity and penetration of water.
15.The surgical gown according to any of the preceding claims wherein the

ultrasonic seam of the sleeves shows an average failure pressure of 63.50 cm H2O in respect of resistivity and penetration of water.
16.The surgical gown according to any of the preceding claims wherein the sleeve seams have an average penetration of 0.25 g.
17.The surgical gown according to any of the preceding claims, wherein the chest area has an average penetration of 0.309g.
18. A foldable surgical gown with impermeability corresponding to open surgery standard comprising,
- a main body formed of a single sheet of 50 gsm spunbond and melt blown fabric, having a front portion and a rear portion, the rear portion provided with an opening including at least one waist closure;
- a pair of sleeves having slanted edges consisting of at least two panels attached adjacent to the neck on two sides of the main body, the front body portion and the sleeves each constitutes a critical zone, the rear portion of the main body including the waist closure constitutes a non-critical zone, wherein the first panel of the sleeves are attached to the upper shoulder extending to the arm pit of the main body by application of ultrasonic sealing procedure, the second panel of the sleeves extending backwardly to the rear portion of the body is glued or stitched, the ultrasonic seam portion comprises at least two dotted line closures provide a first level of protection allowing a minimum fluid flow , and at least two solid line closures provide a

final level of protection disallowing any flow-through of the generated fluid during the process of surgical intervention.
19.The surgical gown according to claim 18, wherein the ultrasonic sealing procedure is used to attach the waist closure to the body of the gown.
20.The surgical gown according to claim 1, wherein the ultrasonic sealing procedure employed to attach the sleeves constitutes a seam-pattern comprising two dotted line closure to provide a first level of protection and one solid line closure to provide final protection to the wearer.
21.The surgical gown as claimed in claim 1 or 18, wherein the ultrasonic sealing pattern adapted to attach the sleeves to the main body constitutes one dotted-line closure to provide a first level of protection, and two solid-line closures providing the final protection to the wearer.
22.The surgical gown according to any of the preceding claims, wherein the ultrasonic fusion complies the parameters of frequency, output, power, speed, roller specification respectively to 20 KHZ, 1400 W, 0-18 min /sec, 51 mm dia with 18mm width.
23. A method of folding a surgical gown with impermeability corresponding to an open heart surgery standard, the surgical gown having a main body with an opening at rear portion and made of a single piece fabric constituting 50 gsm spunbond and melt blown composite fiber, to which respective left and right sleeves are attached through an ultrasonic sealing pattern, the method comprising the steps of:

- folding left and right flaps of the main body at least partially back upon one another to expose a shiny interior surface of the main body;
- folding said left and right sleeves behind the rear portion of said main body;
- folding back said main body along two parallel axial fold lines through the corresponding to the lateral sides;
- folding back the main body along at least one transverse fold line extending parallel to the lateral sides to define at least one waist closure after folding said lateral sides;
- folding said waist closure to keep those horizontally and adjacently placed; and
- folding said main body along a third axial line to form a folded surgical gown.
24.The method according claim 23, wherein said sleeves are folded behind said rear portion of the main body at an angle from the transverse fold line.
25.The method according to claim 24, wherein the sleeves are each folded in at said lateral sides of the main body to cross one another behind said rear portion of said main body.
26.The method according to claim 24, wherein said sleeves are each folded in at said lateral sides of said main body and out at an intermittent position back toward said lateral sides.

27.The surgical gown according to claims 1 and 18, wherein the ultrasonic sealing procedure employed constitutes a beam-pattern comprising three dotted-Jine closures to provide first level of protection and one solid line closure to effect final level of protection.
28.The surgical gown according to claims 1 and 18, wherein the ultrasonic sealing pattern employed comprises four dotted-line closures each providing correspondingly higher level of protection to achieve the desired
impermeability.