Classification, Production and Testing Requirements of Medical Gloves (Part 2)

04, Production process requirements

(I) Relevant requirements for product manufacturing

The production process of medical glove products should be specified. Key processes and special processes should be noted in the process flow chart, and their process control points should be explained. Clarify the use of various processing aids and the control of impurities (such as residual monomers and small molecule residues) in the production process.

Medical glove production line generally includes: ingredients, mold cleaning (hand mold acid and alkali cleaning, hand mold water washing, hand mold immersion in hot water), hand mold immersion coagulant, drying, dipping, drying, curl , Leaching, isolating agent / chlorine treatment, drying, demoulding, vulcanization, drying molding, primary packaging, sterilization (if any), etc. The key procedures and special processes are: leaching, chlorine treatment, vulcanization, primary packaging, sterilization (if any), etc.

The production process of single-use sterile PVC medical examination gloves generally includes: batching, filtering, defoaming, dipping, plasticizing, powdering, sorting, demoulding, packaging, etc. Key processes and special processes include: defoaming, impregnation, plasticizing, packaging, etc.

Attention should be paid to the quality control requirements of raw materials for medical gloves, and the source and quality requirements of raw materials should be clarified. The raw materials should have relatively stable production processes and sources of supply to ensure product quality. The storage of raw materials should be protected from moisture, contamination and pests, especially latex and starch must be stored in an environment that can prevent the growth of microorganisms.

Medical Glove Production Line

(2) Sterilization process requirements

The sterilization process (methods and parameters) and sterility assurance level (SAL) of medical making machine china should be specified, and a sterilization confirmation report should be provided. For the products to be sterilized by the end user, the recommended sterilization process (methods and parameters) and the basis for the recommended sterilization method should be determined. If ethylene oxide is used for sterilization, the requirements for residues and the treatment methods adopted shall be clarified, and research data shall be provided.

(Three) product expiration date

The basis for determining the validity of medical gloves and the relevant verification data should be provided. Refer to EN 455-4-2009 "Requirements and Tests for the Determination of Shelf Life of Disposable Medical Gloves". And research data to maintain the integrity of the package during the stated validity period and transport and storage conditions.

05. Product instruction and labeling requirements

Product descriptions and labels shall comply with the "Medical Device Instructions and Label Management Regulations" (Order of the State Food and Drug Administration No. 6), "Symbols for the labeling, marking and providing information of medical devices for medical devices. Part 1: General requirements" (YY / T 0466.1-2009) and related standards.

(1) The inner packaging shall be clearly marked:

(1) size;

(2) "Left" or "Right" should be marked on the inner packaging;

(3) Powdered gloves should have “Note: Aseptic operation should be used to remove surface powder before surgery to minimize the risk of adverse tissue reactions.” Or “Once the gloves have been treated with any surface powder material, there should be a warning The surface powder should be removed aseptically before surgery. "Or equivalent;

(4) Gloves made of natural rubber latex should have “(product) contains natural rubber latex that can cause allergic reactions” or equivalent instructions;

(5) If the product is declared to contain protein, the specified process limits shall be given;

(6) "Hypoallergenicity" should not be marked.

(2) Unit packaging generally includes the following:

(1) the name or trademark of the manufacturer or supplier;

(2) Materials used;

(3) "Straight fingers" or "curved fingers", or similar words indicating the content of gloves design;

(4) the words "hemp surface" or "glossy surface", "with powder" or "no powder", or similar effects on the type of gloves;

(5) size;

(6) Production batch number, production date, use period or expiration date;

(7) Indicate the product status: "sterilized unless the package is opened or damaged" or "non-sterile";

(8) "One-time use";

(9) the words "surgical gloves" or "examination gloves";

(10) For category 1 gloves, the words "Products are made of natural rubber latex that may cause allergic reactions" are marked.

(11) During storage of the product, do not touch oil, acid, alkali, copper, manganese or other organic solvents. Avoid sunlight or artificial light containing ultraviolet rays. The warehouse should be free of ozone generating devices and kept away from radioactive materials.

(Three) multi-unit packaging

Multi-unit packaging is a box of products with a predetermined number of units of gloves of the same size. The purpose is to facilitate safe transportation and storage. Multi-unit packages are labeled as single packages, and the number of gloves and additional storage instructions should be indicated.

Classification, Production and Inspection Requirements of Medical Gloves (Part 1)

Medical making machine factory share with you:

01. Classification and management of medical gloves

Medical gloves include sterile medical surgical gloves, medical sterile examination gloves, medical examination gloves (not supplied sterile).

Sterile medical surgical gloves, medical sterile examination gloves, management category Ⅱ, original classification code 6866, now classified code 14. Medical examination gloves provided non-sterile, management category I, original classification code 6866, now classified code 14.

Sterile medical surgical gloves are suitable for protective use during clinical surgical operations. They are worn on the hands of surgeons to prevent the spread of dandruff and bacteria to open surgical wounds and prevent the body fluids of surgical patients from being transmitted to medical personnel. The role of two-way biological protection.

Medical (sterile) examination gloves are used to check or touch the patient's condition while being worn on the doctor's hand or fingers to prevent cross-infection between the patient and the user during the medical examination and diagnostic treatment.

Medical Glove Production Line

02. Structural composition of medical gloves

Medical glove production line believes that medical surgical gloves are generally made of natural rubber latex, nitrile rubber latex, neoprene latex, styrene-butadiene rubber r thermoplastic elastomer solution or emulsion, styrene-butadiene rubber emulsion and other materials.

Medical (sterile) examination gloves are generally made of natural rubber latex, nitrile rubber latex, neoprene latex, styrene-butadiene rubber or thermoplastic elastomer solution or emulsion, styrene-butadiene rubber emulsion, polyvinyl chloride, polyethylene and other materials.

Medical gloves are classified according to rubber type, design and surface type, and generally have the following forms:

Divided by rubber type: 1 type, 2 type, 3 type.

For example: rubber surgical gloves, type 1 refers to gloves made from natural rubber latex;

Type 2 is gloves made from nitrile rubber latex, neoprene latex, styrene-butadiene rubber solution or emulsion, thermoplastic elastomer solution or emulsion;

Type 3 is a glove made by mixing or compounding the materials of Type 1 and Type 2.

According to the design style, it is divided into straight type (R type) and curved type (C type).

According to the surface type, it can be divided into: hemp surface (T type), smooth surface (S type), powder (P type), powderless (F type).

03. Test items of medical gloves

(A) sterile medical surgical gloves:

Should comply with GB 7543-2006 "Single-use sterile rubber surgical gloves", GB 24787-2009 "Single-use non-sterile rubber surgical gloves", GB 24788-2009 "Limits of residual powder on the surface of medical gloves, water extraction protein" Requirements.

(2) Medical examination gloves:

Should meet the requirements of GB 10213-2006 "Single-Use Rubber Examination Gloves", GB 24786-2009 "Single-Use Polyvinyl Chloride Medical Examination Gloves", GB 24788-2009 "Limits of Residual Powder and Water Extraction Protein on the Surface of Medical Gloves" Requirements.

(2) Medical examination gloves:

Should meet the requirements of GB 10213-2006 "Single-Use Rubber Examination Gloves", GB 24786-2009 "Single-Use Polyvinyl Chloride Medical Examination Gloves", GB 24788-2009 "Limits of Residual Powder and Water Extraction Protein on the Surface of Medical Gloves" Requirements.

(3) Residual ethylene oxide when sterilized with ethylene oxide

It shall meet the relevant requirements in GB / T 16886.7-2001 "Ethylene Oxide Sterilization Residues in Biological Evaluation of Medical Devices, Part 7"; if there are endotoxin requirements, it shall also comply with YY / T 0616-2007 "Single use Medical gloves biological evaluation requirements and tests.

Common Sense and Misunderstanding of Wearing Medical Latex Gloves

1. Indications for the use of surgical gloves: surgical interventional radiation intervention, central venous catheterization, indwelling catheterization, total parenteral nutrition and preparation of chemotherapy drugs.

2. Indications for the use of inspection gloves: when in contact with the patient's blood, body fluids, secretions and items contaminated with body fluids, such as: intravenous injection, intravenous catheter extubation, inspection, processing equipment, waste disposal, etc.

Medical latex is white latex extracted from rubber tree or leached with rubber particles. It is used to produce medical latex products. Rubber particles, ie 33% polyisoprene, have a particle size of approximately 0.3 m and can be maintained on the particle surface by protein and soap. After adding the vulcanizing agent, medical gloves are prepared by dipping, medical latex tubes are prepared by extrusion, and other medical products are prepared by casting. The formulated medical products meet the medical standards of the corresponding products.

Our company is a machinery manufacturer that mainly researches, develops, designs and produces high-quality latex gloves equipment and finished products. It mainly produces: latex gloves production line china, nitrile gloves production line china, packing machine, pvc gloves equipment, stripping machine and a series of processing equipment. for many years, Fengwang Mining Area is based on the research and development and manufacturing of cutting-edge equipment technology, and provides customers with machinery and equipment services for the entire plant. The difference is that our corporate culture is to become true friends with customers. The difficulties our customers encounter in the process of production and factory establishment are also our difficulties. We will stand with our customers and work together to find solutions.

Fengwang is based on the business philosophy of "aspirations to go high". Always pursuing innovation and breakthroughs, keeping pace with the times. It has a relatively high position in the industry in terms of production line process layout, equipment structure design, and material selection. The complete set of equipment for medical gloves production line is at a relatively advanced technical level in the industry. Its stability, reliability, advancedness and durability are favored by most domestic latex product manufacturers.

Stripping Machine

What is a medical glove: gloves are the standard prevention for medical personnel during work. The purpose of gloves is to prevent hands from being contaminated with microorganisms, to prevent the spread of microorganisms already on the skin or hands, and to avoid damage or reduction of chemicals. Injury of sharps.

Matters needing attention 1. Gloves should be changed between patients with different treatments. 2. After the operation is completed, take off the gloves and wash your hands according to the prescribed procedures and methods. Wearing gloves cannot replace hand washing. Hand disinfection should be performed when needed. 3. When the gloves are found damaged during operation, they should be replaced in time. 4. When wearing sterile gloves, prevent gloves from contaminating.

Hand washing and sanitary hand disinfection should follow the principles: ① When the hands are contaminated by naked eyes such as blood or other body fluids, wash hands with soap (soap) and running water; ② When there is no visible contamination of hands, use quick-dry Hand sanitizer disinfects hands instead of washing hands. The composition characteristics of medical latex products: 1. It has the advantages of high efficiency, wide spectrum, wide pH range, good chemical stability, etc. 2 Use can reduce patient's pain and burden.

Which Kitchen Glove Is Better?

Kitchen gloves are usually made of three materials: the first is natural rubber gloves; the second is nitrile gloves; the third is PVC gloves.

Disposable gloves production lines manufacturer to share with you: rubber gloves are the most commonly used gloves in the kitchen, soft and thick texture, generally there are bumps on the palms of the fingers to increase friction. However, some people are allergic to natural rubber components. If they wear gloves for a period of time, their hands may become itchy or red. So for allergic people, rubber gloves are not a good choice.

scenes to be used:

Can be used in household, industrial, medical, beauty, industrial and agricultural production industries.

PVC gloves are also used in the kitchen and are usually used to handle food. Ordinary PVC gloves are usually thin, disposable gloves that cannot be cooled. However, PVC gloves have certain oil resistance, and when the temperature is between 50 and 70 degrees Celsius, PVC gloves can be used without generating harmful substances. The highest temperature that the human body can contact is 42 degrees Celsius, so peeling a crayfish and taking some food that will not be too cold or hot, there is no problem using PVC gloves.

scenes to be used:

Suitable for clean room, clean room, purification workshop, semiconductor, hard disk manufacturing, precision optics, optical electronics, LCD / DVD manufacturing, biomedicine, precision instruments, PCB printing and other industries.

Sanitary inspection, food industry, chemical industry, electronics industry, pharmaceutical industry, paint and coating industry, printing and dyeing industry, agriculture, forestry, animal husbandry and other industries, labor protection and household hygiene.

Butyronitrile is an organic compound, which is an excellent combination of mechanical strength and chemical resistance. It is a synthetic rubber. Because the combination of the nitrile polymer is very tight, under strict testing, the nitrile glove after pulling is stronger than other gloves. In addition, nitrile gloves have good physical properties, good tear resistance, puncture resistance, and anti-friction properties. They will not rebound immediately after the tension is expanded, and the fatigue of the hand can also be relieved.

Nitrile gloves have the characteristics of acid resistance, alkali resistance, abrasion resistance, oil resistance, and no static electricity. Because it does not contain water-soluble proteins and no chemical residues after the process is improved, it can eliminate skin allergies. So for people with allergies, nitrile gloves are undoubtedly the best choice.

scenes to be used:

Widely used in electronics factory, medical inspection, food industry, housework, chemical industry, aquaculture industry, glass products and scientific research and other industries.

We are latex gloves production line exporter. If you have any needs for my products, please feel free to contact us.

Development Trend Of PVC

China's pvc gloves production line china manufactures synthetic rubber gloves with PVC as raw material through impregnation technology. The equipment of the PVC gloves production line mainly consists of four parts: batching equipment, including mixer, filter bucket, vacuum defoamer, rubber Liquid conveying pump; dipping equipment, including rack, conveying chain, dipping tank, recovery tank machine, drip tank; plasticizing furnace; cooling, rolling lips, dusting, mold release, powder removing equipment, including cooling group, rolling lips group , Dusting group, demoulding module, deflection group. PVC glove production line adopts continuous production method and direct immersion method, uniform film formation, beautiful color, various models and specifications can be produced online at the same time, the production line length is 60 meters, 80 meters and 100 meters and other specifications, high degree of automation, large output, It can be configured with automatic demolding, and the length of production line can be designed and installed according to the customer's production site.

PVC gloves equipment china producing PVC gloves, firstly mix the main raw materials and additives in a special container to a certain proportion to form an emulsion. After filtering, vacuuming, standing, etc., use a pump to mix The material is sent to the dipping tank in the production line. Under normal production conditions, the hand mold on the assembly line automatically enters the dipping tank, the hand mold adhering to the emulsion comes out of the dipping tank in turn, and continuously rotates during the process to make the emulsion on the surface of the hand mold uniform and make the excess emulsion droop. Dripping down. The dripped liquid returns to the dipping tank through the collecting tank. After dripping the excess emulsion, the hand mold moves into the oven with the production line, and the oven temperature is controlled at 230-250 degrees Celsius. Under this condition, the emulsion on the hand is matured and formed. The hand mold coming out of the oven undergoes natural cooling, lip curling, powder coating and other processes. The gloves are manually removed from the hand mold, and the hand mold continuously travels to the dipping tank. After removing the PVC gloves, the finished products will be stored in the warehouse.

Impregnation: The hand mold is immersed in the stock solution in an orderly manner.

Lip curl: Use a moderate and delicate angle to make a lip curl on the cuff part of the glove

Release: Workers quickly and orderly remove the finished gloves from the hand mold.

Packaging: After physical inspection and visual inspection, various packaging

Today, the domestic PVC market continues to be dominated by weak adjustments. The market remains slightly pessimistic about future trends. Under the support of cost, merchants mainly provide stable prices and actively deliver. It has been observed that high level transactions and low price transactions are difficult to reach. National economic data for April was released yesterday, and the market is expected to raise interest rates. At present, oil prices have encountered resistance and it is difficult to resist falling. Domestic energy and chemical products should also fall. Therefore, the PVC market is greatly hindered. The most important thing is that the uncertain economic policy has aggravated the market differentiation, the operator's mentality is unstable, and the market is waiting and seeing. At present, even under the expectation of rising raw material costs and the coming of the peak season, it is difficult for the PVC market to emerge from a weak position in a short period of time. Affected by the flat domestic trading atmosphere, the domestic PVC market's main offer is between 7375 and 7425 tons.

Affected by the rise in markets in other regions, today the markets in Northeast and North China rose by about 50 yuan. It is understood that the current supply in the market is still a little tight, and the market demand is strong. However, due to the current relatively high prices, the bottom line of profits of downstream PVC manufacturers has been touched, so the resistance to rising again is relatively large, and it is expected that the market will be mainly stable in the short term.

Pvc Gloves Equipment China

What Is The Use Of Nitrile Gloves?

The application of gloves in daily life is still very wide, there are many types of gloves, today nitrile gloves equipment suppliers will come to the users to briefly introduce the use of nitrile gloves and what are the advantages, let's take a look below.

Nitrile gloves, latex gloves, hemp surface, latex gloves, are made of high-quality natural nitrile rubber with other additives and processed by special powder-free technology. The product is non-toxic and harmless. Good attachment and flexible use.

 Nitrile Gloves Making Machine China

Advantages of nitrile gloves:

100% pure primary color latex, good elasticity, easy to wear; comfortable to wear, free of oxidants and silicone oils, fats and salts; strong tensile strength, puncture resistance, not easy to break; superior chemical resistance, resistance to certain pH, Resistant to some organic solvents, such as acetone; low surface chemical residue, low ion content, and low particle content, suitable for strict clean room environment.

The use of nitrile gloves:

Nitrile gloves are widely used in food processing, homework, agriculture, medical and other industries. Sunny gloves are widely used in high-tech product installation and commissioning, circuit board production lines, optical products, semiconductors, disk drives, composite materials, LCD displays. Watches, precision electronic components and instrument installation, laboratory, medical and other fields.

nitrile gloves making machine china believes that nitrile gloves can effectively prevent the penetration of organic solvents. Its main advantages are high strength and high elasticity. It is mainly provided to the workstations where the hand is constantly exposed to liquid chemicals, such as chemical storage, organic and inorganic experiments, etc.

Nitrile gloves are not only easy to wear, but also extremely durable. They are resistant to acids, alkalis, abrasion, oil, and static electricity. Because it does not contain water-soluble proteins and no chemical residues after process improvement, it can eliminate skin allergies.

Because the combination of the nitrile polymer is very tight, under strict testing, the nitrile gloves after pulling are more effective in preventing bacteria than latex gloves and other gloves, so that medical personnel and other industry personnel get the best safety guarantee.

The elasticity of nitrile gloves is similar to that of latex, but after the tension is expanded, it will not rebound immediately, and the fatigue of the hand can be eliminated.

Latex Gloves Production Line

Latex allergic reaction. More rare. Redness and itching usually appear within minutes to ten minutes of wearing gloves. Symptoms can be seen throughout the body, often accompanied by reed measles, rhinitis, conjunctivitis, chest rush, heart palpitations, etc. Severe cases may present with difficulty breathing, tachycardia, decreased blood pressure, and even anaphylactic shock, sudden death, etc.

Waterproof, acid and alkali resistant gloves should be carefully inspected before use to investigate whether the appearance is damaged. A simple method is to breathe into the gloves, pinch the sleeve with your hands, and investigate whether there is air leakage. Leakage cannot be used; the electrical insulation performance should be regularly checked, and those that do not meet the requirements should not be used; rubber, plastic and other protective gloves should be washed and dried after use, to prevent high temperature during storage, and sprinkle talc powder on Anti-blocking.

The selection of gloves should be based on their weight. Boxing gloves punching is not just the strength of an arm, but the waist's turning force at the foot. Excessive pounds of gloves can lead to irregular punching, which will jeopardize the fighter, so choose based on your weight. When wearing gloves, first of all, see if you can prevent blood flow from your wrist. Swing your hands down randomly to see if they will loosen. Then, make two punches in the air, two back punches and one back punch. If you find that you haven't pulled your fist because of the weight of the glove, then it is clear that the glove is suitable for you. Then, color is a more mind-blowing job. A seasoned player will definitely not choose colors at will. He must choose colors according to his opponents. Generally speaking, two pairs of boxing gloves with the same weight are prepared, one is red. A black, red makes people see simple excitement. If you want to get a particularly violent opposition, you should use red. Black is generally used for defense. It can also give the opponent a sense of depression. Generally speaking, boxing gloves are more powerful and useful. The player's determination to damage, speeding up his becoming impetuous, limiting his play, is defensive. The gloves are also very well maintained. Use a soft cloth to stick a little (but not a little) water to wipe off the sweat from the gloves. Do not wipe directly. Then you will directly change the sweat on the gloves. It will corrode over time. , Resulting in trachoma on the gloves, of course, do not wipe with disinfectant paper towels. A good pair of gloves has a slow internal deformation moment, so don't rush to replace them.

For many years, latex gloves production line suppliers is based on the research and development and manufacturing of cutting-edge equipment technology, and provides customers with turnkey engineering services for the entire plant. We not only have a strong technical background, Have the most sincere after-sales service support. The difference is that our corporate culture is to become true friends with customers. The difficulties our customers encounter in the process of production and factory establishment are also our difficulties. We will stand with our customers and work out solutions together.

Latex Gloves Production Line

Practice has proved that Fengwang develops latex gloves production line. The complete set of equipment is at a relatively advanced level in the industry. Its stability, reliability, advancedness and durability are favored by most domestic latex product manufacturers.

Not only do we need sun protection, like some of the equipment around us also need to protect them. Frequent exposure in the sun will not only fade the surface, but also greatly reduce the life of these items, not only We are afraid of ultraviolet radiation. These devices also need to protect them from sun. Usually, they are placed in a cool place and not in the place where the sun is exposed. These sun protection methods can better protect them. , Increase their longevity, let them create greater economic benefits for us. latex gloves making machine follows the promotion of urbanization and the continuous industrialization of the world. The demand for safety products in China and shopping malls around the world is immeasurable, especially for various high-quality protection Demand for gloves.

The quality of latex gloves is also different. Most of the latex gloves produced rarely use pure rubber. In order to reduce the cost, more or less accessories will be added. Declining the quality of latex gloves has also lowered prices. The factor is the problem of the weight. The thicker the glue is, the thicker it is. The thicker the weight, the heavier it is.

The material of this product is good. It is not ordinary cloth and plastic fiber. If it is only cloth and ordinary plastic fiber, it cannot be used in this industry. And our industrial glove product is the latest and most durable latex, so we can see that this product has a much better effect on this chemical insulation. This product has a very good workmanship, and it is more effective to protect our hands. These are the reasons. We see that most workers now choose to wear this product during construction, so that it is safer during construction. Feel it.