WO2001017382A1

WO2001017382A1 - Surgical gown with closure device

Info

Publication number: WO2001017382A1
Application number: PCT/AU2000/001040
Authority: WO
Inventors: Gary Kara Deirmendjian
Original assignee: Medsearch R & D Pty Ltd
Priority date: 1999-09-02
Filing date: 2000-09-01
Publication date: 2001-03-15
Also published as: AUPQ262699A0

Abstract

A shielded closure device (21) for use with a disposable surgical gown is disclosed. The device includes a fastener element (20) having one side affixed to an inner side of the sterile flap (14). An opposed side of the fastener element having means (23, 25') for adhering the fastener element (20) to the gown and having an associated removable masking element (26) covering the adhering means to prevent operation of the fastener element. A shielding element associated with the masking element (26) and operable, in use, to remove the masking element to allow operation of the fastener element (20), the flap (14) being double folded in use to form three sections, an inner sterile section (34) adjacent a free edge of the flap, an outer non-sterile section (35) on the opposite side of the flap to that of the sterile section (34) and connecting section (36) joining the sterile and non-sterile sections to the gown body. The one side of the fastener element (20) is affixed to the flap (14) in the non-sterile section (35), the non-sterile section (35) has releasable attachment means (41, 42) for holding the folded flap (14) in position against the outer surface of the gown. The shielding element (21) extends around a free edge of the sterile flap at least in part over an area of the sterile section (34) opposed to an area of the non-sterile section (35) where the fastener element (20) is affixed and has a tab portion (31) extending into the connecting section (36) such that the tab portion (31) extends from the flap (14) when in the double folded configuration.

Description

Surgical gown with closure device

TECHNICAL FIELD

The present invention relates to a disposable gown design and corresponding robing technique. Although the invention will be described in relation to a sterile surgical gown manufactured from a cellulose or polypropylene based fabric as typically utilised in the current disposable gowns, the invention is not limited to using such materials or for use in such applications. BACKGROUND ART

Operating gown design must consider the protection of the surgeon from fluid penetration by providing an impervious barrier for the torso and forearm. The gown must be easy and quick to put on for both the wearer and gown assistant. It must be more convenient, cheaper and ecologically sound than the non-disposable cloth gowns. The highest reasonable standard of sterility of the operating field must be achieved to avoid surgical patient contamination and post operative wound infections.

Current disposable gown manufacturers have all adopted the same overall design which is similar to that of the traditional cloth gown. The only apparent innovations are in the manufacturing techniques adopted and material types used.

Figures 1a to c illustrate the front, back and top views respectively of the current gown design which is used extensively. It consists of neck ties 1 (hook and loop type fasteners and press studs are sometimes used here instead of ties), mid-back ties 2, sterile ties 3 and 4, and a sterile paper tie link 5, 6 and 7 are the non-sterile and sterile flaps respectively. The sterile flap 7 is folded back and held there by the connection of the sterile tie 3, paper link 5 and left side sterile tie 4, in the front of the gown. Figures 2a and b illustrate the applied gown from the front and the back respectively. The closure of the unfolded sterile flap 7 is shown in Figure 2b. The sterile flap 7 covers the non-sterile flap 6 and non-sterile tie connections 2. The neck tie closure 1 is exposed. Figure 2a also shows the sterile tie connection between ties 3 and 4.

The sterile zone 8 can be defined as a three-dimensional arc wedge as shown in Figures 3a and b. The base and the top of the wedge extends from the waist to the nipple line with the tip at the centre of the surgeon. The sides of the wedge radiate at an angle 13 of approximately 40° to the back plane of the surgeon.

Prior to putting on the gown, the surgeon is first scrubbed and then proceeds to unfold the gown. This is done by holding the gown at the neck and letting it unfold towards the ground without actually reaching it. The surgeon then proceeds to pass both arms through the respective arms of the gown alone. The gloves are put on next by the surgeon. The gown assistant steps behind the surgeon while they are applying the gloves or right afterwards and begins to apply the ties at the rear of the gown. The assistant first applies the neck tie 1 and then proceeds to tie the mid-back tie 2 (see Figure 1 ). Both are non-sterile ties. Once this is complete the gown assistant 10 then moves to the front right side of the surgeon 9 as shown in Figures 4a and b. The surgeon 9 then undoes the connection of the sterile tie 4 from the paper tie link 5 while maintaining its connection with the sterile tie 3. The tie link 5 is held in the right hand of the surgeon 9 who then reaches it out to the assistant 10 to hold. At this point, either the surgeon 9 turns counter clockwise on the spot 11 with arms raised high while the assistant 10 stands still as in Figure 4a, or the surgeon 9 stands still with the arms raised high while the assistant 10 walks clockwise 12 around the back of the surgeon. In either case, the assistant will end up on the front left side of the surgeon while still holding the paper tie link 5. The surgeon then pulls the sterile tie 3 off the link 5 and proceeds to tie it to the sterile tie 4 and thus makes the final connection as shown in Figure 2a. Gown assistants are usually unscrubbed (i.e. unclean). Sometimes the final tie is assisted by a scrubbed (i.e. clean) assistant. The current gown design presents a number of problems requiring attention. The surgical gowns are commonly put on in the operating theatre or at least the final sterile tie is completed in the theatre. Discipline in the operating room is important to minimise accidental contamination of the gown and by the gown. One way of decreasing contamination is by reducing air currents and the amount of movement in the operating theatre, thereby decreasing the opportunity for contamination.

The sterile tie 3 may break during the final twirl if the paper link 5 is pulled too tightly or is yanked by the assistant 10 (see Figure 4). It is more common for the sterile tie 3 to become disconnected with the paper link 5. In both instances, the damaged gown is discarded and a new gown must be put on. During the application of the sterile flap 7 using the sterile tie 3, air currents are generated during the turning process illustrated in Figure 4. This is true in either case. The case where the assistant turns around the surgeon while holding the paper link 5 is more severe since the sterile flap 7 acts as a sail, causing air to move, and the general range of movement is much larger. When the surgeon 9 turns on the spot for the final sterile tie 3 application as shown in Figure 4a, the unclean back of the surgeon may come into contact with sterile draping in the theatre.

Confusion often occurs as to which direction one must turn during the final step of gown application. Throughout the application of the current gown it becomes necessary for the surgeon's hands to approach the extremes of the sterile zone a number of times (see Figure 3). When commencing the sterile flap application, the sterile paper tie link 5 (see Figure 4) is handed to the gown assistant. The surgeon's right hand is at the right extreme of the sterile zone. When the turn is complete, the surgeon's left hand is at the left extreme of the zone as it receives and disconnects the sterile tie 3 from the link 5 and proceeds to tie it to 4 with both hands. Both arms are raised during the turn thus approaching the upper ceiling of the sterile zone. The right hand of the surgeon comes close to the unclean hand of the gown assistant as the assistant receives the sterile tie link 5. The use of the link provides a false sense of security to both parties. The sterile zone of the surgeon is invaded by the body of the assistant during the application of the sterile flap 7. When the final tie 3 is assisted by a sterile assistant, then the unclean back of the surgeon invades the sterile zone of the sterile assistant during the turn. The gowning procedure is cumbersome and at times final tie-up is left undone. When the gown is fully worn, the sterile straps (i.e. 3 and 4 in Figure 2a) on the left side remain exposed. During the operation, these ties may get entangled with the surroundings (i.e. with stands, medical devices, etc.) and cause tearing. A new gown must be used in order to maintain sterility.

Our earlier Australian Patent Application No. 39885/97 and United States Patent No. 5,901 ,376 relate to a gown and shielded closure device therefore and are incorporated herein by cross-reference. SUMMARY OF THE INVENTION

The present invention seeks to overcome or at least ameliorate one or more of the problems of the prior art by providing an improved closure device. According to one aspect, the present invention provides a shielded closure device, for use with a gown of the type described, including a fastener element having one side affixed to an inner side of the sterile flap, an opposed side of said fastener element having means for adhering said fastener element to said gown and having an associated removable masking element covering said adhering means to prevent operation of said fastener element, a shielding element associated with said masking element and operable, in use, to remove said masking element to allow operation of the fastener element, said flap being doubled folded in use to form three sections, an inner sterile section adjacent a free edge of the flap, an outer non-sterile section on the opposite side of the flap to that of the sterile section and connecting section joining the sterile and non- sterile sections to the gown body, said one side of the fastener element being affixed to said flap in the non-sterile section, said non sterile section having releasable attachment means for holding the folded flap in position against the outer surface of said gown, said shielding element extending around a free edge of said sterile flap at least in part over an area of said sterile section opposed to an area of said non-sterile section where said fastener element is affixed and having a tab portion extending into said connecting section such that said tab portion extends from said flap when in said double folded configuration.

Preferably, said means for adhering comprises an adhesive layer. For preference, said fastening means is affixed to the inner side of the gown flap by a further adhesive layer. Optionally, the masking element may be formed by the shielding element. For preference, said shielding means has means for adhering it to the masking element and associated portions of said gown flap.

According to another aspect the present invention provides a shielded closure device, for use with a gown of the type described, including a carrier having applied to one side thereof a first double sided differential adhesive layer, one surface of the first double-sided differential adhesive layer being a low strength adhesive surface and an opposed surface thereof being a high strength adhesive surface, the high strength adhesive surface of the first double-sided differential adhesive layer being adhered to said carrier and a first liner being applied to said low strength adhesive surface of the first double-sided differential adhesive layer, the other side of said carrier having applied thereto at a location opposed to the first double-sided differential adhesive layer, a second double sided differential adhesive layer, one surface of the second layer being a low strength adhesive surface and an opposed surface thereof being a high strength adhesive surface, the high strength adhesive surface of the second layer being adhered to the other side of said carrier and a first, uncoated side of a second liner being applied to said low strength adhesive surface of the second double-sided differential adhesive layer, a third double-sided adhesive layer being applied to an opposed, coated side of the second liner and a fourth double-sided differential adhesive layer being applied to said other side of said carrier at a location spaced from the location of said second double sided differential adhesive layer, one surface of the fourth double-sided differential adhesive layer being a low strength adhesive surface and an opposed surface thereof being a high strength adhesive surface, the low strength adhesive surface of the fourth double-sided differential adhesive layer being adhered to said other side of said carrier. Unless the context clearly requires otherwise, throughout the description and the claims, the words 'comprise', 'comprising', and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to". BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:-

Figure 1a shows a pictorial view of the front of a prior art surgical gown; Figure 1 b shows a rear pictorial view of the gown of Figure 1a; Figure 1 c shows a top pictorial view of the gown of Figure 1 a;

Figure 2a shows a pictorial view of the front of a prior art surgical gown when fitted to the surgeon;

Figure 2b shows a rear pictorial view of the gown of Figure 2a; Figure 3a shows a top pictorial view of a surgeon illustrating the sterile zone;

Figure 3b shows a front pictorial view of the surgeon of Figure 3a; Figures 4a and 4b show a top pictorial view of the prior art method of fitting the gown of Figure 1a;

Figure 5 shows a plan view of the shielding element of the shielded closure device according to a preferred embodiment of the present invention;

Figure 6 shows an underside view of the shielding element of Figure 5; Figure 7 shows a plan view of the main adhesive element of the shielded closure device according to a preferred embodiment of the present invention; Figure 8 shows a side view of the main adhesive element of the shielded closure device of Figure 7:

Figure 9 shows an enlarged side view of the encircled portion of the main adhesive element of the shielded closure device of Figure 8;

Figure 10 shows a pictorial view from the left side of the wearer of the adhesive device of Figure 5 and 6 applied to the flap of a gown and Figures 10a to 10e show an enlarged view of the outlined region of Figure 10 illustrating the sequence of operations in closing the flap; Figures 1 1 , 1 1 a to 1 1 c show similar views to Figures 10 to 10e but from the right side of the wearer;

Figure 12 shows a pictorial representation of a plan view of an alternate embodiment of the shielded closure device; Figure 13 shows a pictorial representation of a side view of the alternate embodiment of Figure 12; and

Figure 14 shows a pictorial representation of an underside view of an alternate embodiment of Figure 12.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The closure device according to an embodiment of the invention comprises two interacting components, a main adhesive component 20 for closing the gown flap 14 and a shielding device 21 to enable the adhesive component to be positioned and activated to close the gown flap 14 in a sterile manner. Referring to Figures 7, 8 and 9, show in detail the main adhesive component 20. The component 20 comprises a foam body 22 with opposed sides 23 and 24 having an aggressive adhesive layer 25, 25'. One side 24 is provided with a peelable liner 26 having one side silicon-coated to enable peeling from the adhesive layer 25. The liner 26 is arranged to be larger than the body 22 to prevent inadvertent adhering of the component 20. The component 20, in use, is applied to the inside of the gown flap 14 with one side 23 and adhesive layer 25' adhered to the gown material and the other side being covered by the peelable liner 26. This can be considered the non- ' activated state of the adhesive component 20. Referring now to Figures 5 and 6, the shielding device 21 will be described in detail. The device 21 comprises an elongate paper sheet 28 having a base portion 29, a tapered mid portion 30 and a tip portion 31 . The mid portion 30 tapers at the sides to the tip portion 31 as shown in the Figures. The "paper" can be formed from a cellulose base sheet, plastic or the like. The underside of the sheet 28 (as shown in Figure 6) is provided with a longitudinally extending strip 32 of low strength adhesive which may be in the form of an adhesive layer, transfer tape or double sided tape with the ease release side exposed. The adhesive strip 32 extends the full length of the elongate paper sheet 28. The portions 29, 30 and 31 are delineated by folds or crease lines formed in the sheet 28. In this embodiment a hole 33 is also provided in the mid portion 30 of the sheet.

Figures 10a to 10e show the area of Figure 10 in enlargement and illustrate the sequence of operations in using the adhesive component 20 to close the gown 40 without contacting the sterile areas of the gown.

The gown flap 14 is double folded with a sterile section 34 of the flap 14 being arranged to face inwardly. When folded, the flap 14 can be considered to consist of three sections, an inner sterile section 34, an outer non-sterile section 35 (on the opposite side of the flap to that of the sterile section) and connecting section 36 joining the sterile and non-sterile flap sections to the gown.

The adhesive component 20 is applied to the sections of the gown flap as shown in Figures 10 and 11. The adhesive layer 25' of adhesive component is affixed to the outer non-sterile section 35 with the peelable liner 26 facing outward.

The shielding device 21 is applied over the liner 26 with its mid portion 30 positioned to coincide with the location of the adhesive component 20. The adhesive strip 32 is adhered to the liner 26. The elongate paper sheet is then positioned to extend across the flap so that the base portion 29 is located on the area of gown material adjacent to the location where the adhesive component 20 is adhered to the flap 14. This positioning enables direct pressure to be applied to adhesive component through the flap material by pressing on the base portion of the shielding device. The tip portion 31 extends across the flap to be located on and adhered to the connecting section 36.

As shown in Figures 10a and 11a, when the flap 14 is double folded only the tip 31 is exposed. The double folded flap 14 is held in position against the gown by, in this embodiment, a press stud attachment 41 , 42. One component 41 of the press stud is located on the non-sterile section 35 of the flap 14 and the other component 42 is positioned an appropriate location on the gown to enable engagement to hold the folded flap against the surface of the gown. The hole 33 in the shielding element allows the press stud components to engage therethrough. It will be appreciated that other alternate attachment means can be used such as hook and loop fasteners. In such cases, the hole 33 would not be required.

When the flap 14 is to be closed, the tip portion 31 is lifted from the gown flap connecting section 36 as shown in Figure 10b and the press stud 41 , 42 detached from the gown surface. As the flap is unfolded by pulling on the tip 31 , the liner 26 is removed from the outer side of the adhesive component by the strip 32 to expose adhesive layer 25 as shown in Figures 10c, 11 b and 11 c. The flap 14 is then closed by bringing the exposed adhesive region 25 into contact with the gown as shown in Figure 10d. The adhesive region 25 is pushed into contact in a sterile manner by applying pressure to base portion 29 of the shielding device 21. The remaining base portion 29 of the shielding device is then removed from the flap through continued pulling on tab 31 to leave the flap closed as shown in Figure 10e. It will be appreciated that this sequence of operations enable the flap to adhesively close without any non- sterile contact with the sterile outer section of the flap 14.

In an alternative arrangement, the adhesive component 20 may comprise a moulded hook type fastener which provides a high shear strength attachment to the gown material while at the same time have a low peel strength allowing easy disengagement. When the gown is fitted the forces applied to the closure are shear forces thus the fastener provides a high strength closure while allowing easy opening when a peeling or tensile force is applied to the fastener. With such an arrangement, the shielding sheet 28 is provided with an aperture adjacent the fastener to allow contact with the surface of the gown when pressure is applied to the base portion 29.

In yet another embodiment the shielded closure device may be formed from a complex of adhesive and liner layers which enables simplified production using standard multilayer production facilities. This further embodiment is illustrated in Figures 12 to 14. - lo ¬

in this embodiment, the shielded closure device 49 is formed from a base main paper carrier 50 (for example, 1 10GSM offset printing paper) to which is applied an transversely extending double-sided layer of differential adhesive 51 . This adhesive layer 51 has a high strength surface 52 applied to the carrier 50 and a low strength surface 53 applied to a liner 54. The differential adhesive layer 51 is typically formed from a double-sided adhesive tape using acrylic based adhesives and a polyester carrier, for example 3M-9415 manufactured by the Minnesota Mining & Manufacturing Company. The liner 54 is typically a glassinated paper with a silicon coating on one side. The underside of the carrier 50 has a further series of adhesive/liner layers formed on it surface at a location opposed to the location of the layer 51 . A double-sided layer of differential adhesive 55 is applied to the carrier 50 with its high strength surface 56 applied to the carrier 50 and its low strength surface 57 applied to side 58 of liner 59. Side 58 of the liner 59 has a non-coated grippable surface. This double-sided differential adhesive is typically formed of similar materials to those described above. A further layer of double sided adhesive 60 is then applied at the same location with one surface 61 of the adhesive applied to the free, coated, easy-release side 62 of the liner 59 and the other adhesive surface 63 remaining free. A further layer of differential double sided adhesive 64 is applied to the carrier 50 at a location longitudinally spaced along the carrier 50 from the location of the adhesive/liner layers 55-59. This layer 64 has low strength surface 65 applied to the carrier 50. The high strength surface 66 is left free. In use, the shielded closure device is applied to the gown as follows. The device is applied to the outer surface of the flap 14 using the free adhesive surface 66 with the carrier 50 being aligned with the edge of the flap along fold line 67. The carrier 50 is then folded about the fold line 67 to bring adhesive surface 63 into contact with the inner surface of the flap 14. The liner 54 is then removed to expose the low strength surface 53. The tab 68 is then folded along fold line 69 together with the edge of the gown flap 14, the folded flap being tacked to the gown body using the exposed low strength surface 53 leaving the tab 68 exposed. The device 49 is now ready for use when the gown is to be worn.

To assist adhesion of the closure device 49 to the material of the gown a landing zone of single sided adhesive material may be applied to the gown body in a region where the closure device is to be applied. The non-adhesive side of this zone is formed of a material which assists adhesion of the closure device to the gown body. Typically this zone is formed of a single sided acrylic based tape having a high strength, complex surface polyester backing, for example 3M Scotchpar™-3533, manufactured by the Minnesota Mining & Manufacturing Company.

The closure device 49 is formed using known techniques of applying layers of the material. The carrier material is fed off a roll having a width corresponding to the eventual length of the carrier strip along a path having a number of liner/layer applying stations. The adhesive and liner layers are then applied from a number of rolls of the required layer materials positioned at the stations along the path of the carrier material, the roll of adhesive layer 63 being axially offset from the other rolls to provide the required longitudinal spacing therefrom. When all the layers have been applied, the carrier material is cut into strips equivalent to the width of the required device. This method enables a cost effective and high speed method of production of the complex adhesive arrangement.

The method of application of the gown can be described as follows. Prior to putting on the gown the surgeon is first scrubbed and then proceeds to unfold the gown. This is done by holding the gown at the neck and letting it unfold towards the ground without actually reaching it. The surgeon then proceeds to pass both arms through the respective arms of the gown alone. The gloves are put on next by the surgeon. The gown assistant steps behind the surgeon while they are applying the gloves. Up to this point the application technique is identical to that of the current gown. From here the gown assistant steps behind the surgeon and proceeds firstly to apply the neck tie 13. Secondly the mid-back ties 15 are applied. A desired level of tension or gown comfort may be achieved across the stomach region of the surgeon during the application of this tie by providing direct feedback to the assistant. This step may be taken a number of times without any concern of potential loss of sterility as is the case in current gowns (once the sterile tie is released from the paper link it is very difficult to adjust for comfort). Since the ties 15 are located symmetrically at the rear of the gown, when they are pulled a symmetrically comfortable fit may be achieved more readily.

Thirdly, the assistant holds the shielded adhesive device 20, 21 by the tip 31 using their left hand and pulls continuously. The flap 14 and the attached device 20, 21 is folded back on itself as shown in Figures 10a and 11 a and held in place by the press studs 41 , 42. The sterile flap 14 then unfolds in a controlled manner when the press stud is detached from the gown body, to reveal the outer side of sterile flap 14. As the tip 31 is continued to be pulled the adhesive region 25 is exposed as shown in Figures 10c, 11 b and 11c. The flap 14 is then closed by bringing the exposed adhesive region 25 into contact with the gown as shown in Figure 10d. The adhesive region 25 is pushed into contact in a sterile manner by applying pressure to large base portion 29 and thus covering all of the ties and non-sterile flap 16. The shielding device 21 is then removed by removing the remainder of the strip 32 attached to the flap 14. This concludes the gown application.

When using the device described in the embodiment of Figures 12-14, the flap 14 and attached device 49 are held in a folded configuration by the low strength surface 52. Similarly to above, the assistant holds the shielded adhesive device 49 by the tab 68 using their left hand and pulls continuously. The sterile flap 14 then unfolds in a controlled manner when the low strength surface 52 is detached from the gown body, to reveal the outer side of sterile flap 14. As the tab 68 is continued to be pulled the adhesive region 61 is exposed by removal of liner 59. The flap 14 is then closed by bringing the exposed adhesive region 61 of double sided adhesive layer 60 into contact with the landing zone on the gown. The other surface 63 of the adhesive layer 60 being previously applied to the gown flap 14 during fitting of the shielding device 49. The adhesive region 61 is pushed into contact in a sterile manner by applying pressure to the side of the carrier 50 opposed to the adhesive region and thus covering all of the ties and non-sterile flap 16. The shielding device 49 is then removed by using tab 70 to peel off the remainder of the carrier 50 attached to the flap 14.

The invention offers a simple three-step gown application technique. The gown assistant performs all three steps while at all times remaining behind the surgeon. The need for the assistant to approach and at times invade the surgeon's sterile zone is totally eliminated. The need for any sterile tie transaction between the surgeon and the assistant is also eliminated. The surgeon's hands are contained within the sterile zone and far from the zone extremes as well as far from the assistant, at all times during the gown application. There is no need with this invention for the surgeon to raise his arms (i.e. during the twirl), to approach the right extreme of the zone with their right hand (i.e. handing the sterile paper link 5 to assistant), and to approach the left extreme zone with their left hand (to pick up the sterile tie 3 from assistant and to attach it to sterile tie 4). There are no exposed ties since all the ties are contained underneath the sterile flap 14 once it is applied. This reduces the risk of tie failure due to entanglement and/or material rupture. With this invention there is no requirement for both parties to move about during the full robing process. This helps reduce the introduction of air currents and general movement and thus reduces the risk of contamination in the operating theatre. It will be appreciated that further embodiments and exemplifications of the invention are possible without departing from the spirit or scope of the invention described.

Claims

CLAIMS:

1. A shielded closure device, for use with a gown of the type described, including a fastener element having one side affixed to an inner side of the sterile flap, an opposed side of said fastener element having means for adhering said fastener element to said gown and having an associated removable masking element covering said adhering means to prevent operation of said fastener element, a shielding element associated with said masking element and operable, in use, to remove said masking element to allow operation of the fastener element, said flap being doubled folded in use to form three sections, an inner sterile section adjacent a free edge of the flap, an outer non-sterile section on the opposite side of the flap to that of the sterile section and connecting section joining the sterile and non-sterile sections to the gown body, said one side of the fastener element being affixed to said flap in the non-sterile section, said non sterile section having releasable attachment means for holding the folded flap in position against the outer surface of said gown, said shielding element extending around a free edge of said sterile flap at least in part over an area of said sterile section opposed to an area of said non-sterile section where said fastener element is affixed and having a tab portion extending into said connecting section such that said tab portion extends from said flap when in said double folded configuration.

2. A shielded closure device according to claim 1 wherein said means for adhering comprises an adhesive layer.

3. A shielded closure device according to claim 1 wherein said fastening means is affixed to the inner side of the gown flap by a further adhesive layer.

4. A shielded closure device according to claim 1 wherein the masking element is formed by the shielding element.

5. A shielded closure device according to claim 1 wherein said shielding means has means for adhering it to the masking element and associated portions of said gown flap.

6. A shielded closure device , for use with a gown of the type described, including a carrier having applied to one side thereof a first double sided differential adhesive layer, one surface of the first double-sided differential adhesive layer being a low strength adhesive surface and an opposed surface thereof being a high strength adhesive surface, the high strength adhesive surface of the first double-sided differential adhesive layer being adhered to said carrier and a first liner being applied to said low strength adhesive surface of the first double-sided differential adhesive layer, the other side of said carrier having applied thereto at a location opposed to the first double-sided differential adhesive layer, a second double sided differential adhesive layer, one surface of the second layer being a low strength adhesive surface and an opposed surface thereof being a high strength adhesive surface, the high strength adhesive surface of the second layer being adhered to the other side of said carrier and a first, uncoated side of a second liner being applied to said low strength adhesive surface of the second double-sided differential adhesive layer, a third double- sided adhesive layer being applied to an opposed, coated side of the second liner and a fourth double-sided differential adhesive layer being applied to said other side of said carrier at a location spaced from the location of said second double sided differential adhesive layer, one surface of the fourth double-sided differential adhesive layer being a low strength adhesive surface and an opposed surface thereof being a high strength adhesive surface, the low strength adhesive surface of the fourth double-sided differential adhesive layer being adhered to said other side of said carrier.