Flexible rubber article and method of making

• US 5,601,870 A
• Filed: 05/19/1995
• Issued: 02/11/1997
• Est. Priority Date: 06/10/1992
• Status: Expired due to Term

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Maxxim Medical, Inc. (UBS Ag)
• Inventors: Muschelewicz, Adana, Chen, Fung-Bor, Haung, Wu-Nan, Manwill, Niles R.
• Primary Examiner(s): Seidleck, James J.
• Assistant Examiner(s): Williamson, Michael A.
• Application Number:
  US08/445,229
• Time in Patent Office: 634 Days
• Field of Search: 428/421, 428/423.1, 428/423.9, 428/493, 2/159, 2/167, 2/168, 2/DIG. 7, 525/123, 525/125, 525/127, 427/2, 427/3, 427/133, 427/299, 427/314, 427/372.2, 427/384, 427/385.5, 427/402, 427/407.1, 427/413
• US Class Current: 427/133
• CPC Class Codes: A61B 42/00 Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 41/22 Making multilayered or multicoloured articles
• CPC Class Codes: B32B 25/04 comprising rubber as the main or only constituent of a layer, which is next to another layer of the same or of a different material next to a layer of a particular substance B32B9/043; next to a bituminous or tarry layer B32B11/044; next to a water setting substance layer B32B13/042; next to a metal layer B32B15/06; next to a glass layer B32B17/063; next to a layer formed of natural mineral fibres or particles B32B19/043; next to a wood layer B32B21/045; next to a cellulosic plastic layer B32B23/046
• CPC Class Codes: Y10T 428/1386 Natural or synthetic rubber or rubber-like compound containing
• CPC Class Codes: Y10T 428/3154 Of fluorinated addition polymer from unsaturated monomers
• CPC Class Codes: Y10T 428/31551 Of polyamidoester [polyurethane, polyisocyanate, polycarbamate, etc.]
• CPC Class Codes: Y10T 428/31569 Next to natural rubber
• CPC Class Codes: Y10T 428/3183 Next to second layer of natural rubber

Abstract

A multi-layer flexible article includes a first layer of natural rubber, a second layer of natural rubber, polyurethane, poly(acrylamide/acrylic acid) and polyethylene oxide and a third layer of acrylic copolymer and fluorocarbon telomer resin. The article is preferably a glove formed by the method of dipping a hand shaped mold into baths containing aqueous emulsions of the components used to form the layers. Gloves manufactured according to the method are substantially wet-hand and dry-hand donnable as compared to powdered latex gloves of similar size. The finished gloved is water washed and wet autoclaved to substantially reduce the protein content from the natural rubber and substantially remove other water extractable allergenic moieties. The washing and autoclaving renders the glove substantially hypoallergenic as compared to gloves not so treated.

Claims

1. A method for making a multi-layer glove for use in medical procedures comprising:

dipping a cleaned and coagulant coated hand mold having a surface in a first bath comprising an anionic emulsion of aqueous natural rubber latex;

forming a first film of said latex on said surface;

removing said mold having said film from said first bath;

dipping said mold having said first film in a second bath comprising an aqueous emulsion of anionic natural rubber latex, polyurethane latex, poly(acrylamide-acrylic acid, sodium salt) and polyethylene oxide;

forming a second film from said emulsion of said second bath over said first film;

removing said mold having said second film over said first film from said second bath;

dipping said mold having said first film and said second film into a third bath containing an aqueous emulsion of an acrylic copolymer and a fluorocarbon telomer resin;

forming a third film over said second film and said first film from said third bath emulsion;

removing said mold having said third film over said second film and said first film from said third bath;

drying and curing said films on said mold to form a multi-layer unitary structure having a surface for contacting a wearer on said form;

stripping and everting said unitary structure from said mold thereby exposing on said structure a surface for contacting a patient;

applying a coating of lubricant to at least one of said surfaces of said structure;

washing and autoclaving said structure; and

tumbling dry said structure, wherein said method results in formation of a glove.

2. The method of claim 1 wherein said first bath for forming said patient contacting layer is an aqueous emulsion having about 25 to 30% total solids content and a pH about 9 to 11 comprising an anionic emulsion of natural rubber latex.

3. The method of claim 1 wherein said second-bath for forming said intermediate layer is an aqueous emulsion having about 10 to 20% total solids content and a pH about 7 to 10 comprising an anionic emulsion of natural rubber latex, an anionic emulsion of an aliphatic polyester polyurethane, a sodium salt of poly(acrylamide/acrylic acid) and polyethylene oxide.

4. The method of claim 1 wherein said third bath for forming said patient contacting layer is an aqueous emulsion having about 1.5 to 4% total solids content and pH about 7 to 10 comprising acrylic copolymer and fluorocarbon telomer resin.

5. The method of claim 1 wherein said washing and autoclaving step comprises a water wash for about 5 to 10 minutes at about 150°

to 200°

F. and a wet autoclaving cycle for about 10 to 20 minutes with a peak temperature about 180°

to 280°

F. which serves to substantially denature and extract proteins found in natural latex and substantially remove water extractable allergenic moieties, thereby rendering said gloves hypoallergenic compared to gloves not so treated.