Requirements for Classification, Production and Testing of Medical Gloves

As one of the important medical protection products for epidemic prevention and control, medical gloves play an important role in the protection of medical personnel. Medical making machine factory share this article for you:

1. Classification and management of medical gloves

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

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

Sterile medical surgical gloves are suitable for protective use during clinical surgical operations. They are used on the hands of surgical staff to prevent the spread of dander and bacteria to open surgical wounds, and prevent the spread of surgical patients' body fluids to medical staff. The role of two-way biological protection.

Medical (sterile) examination gloves are used to check or touch the patient's condition on the doctor's hand or finger to prevent cross infection between the patient and the user during the medical examination and diagnosis and treatment.

2. The structure of medical gloves

Medical surgical 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 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, surface type, and generally have the following forms:

According to the type of rubber, it can be divided into 1 type, 2 type and 3 type.

Such as: rubber surgical gloves, type 1 refers to gloves made of natural rubber latex;

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

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

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

According to the surface type, it is divided into: pitted surface (T type), smooth surface (S type), with powder (P type), without powder (F type).

3. Test items for medical gloves

(1) Sterile medical surgical gloves

It should comply with GB 7543-2006 "Disposable Sterilized Rubber Surgical Gloves", GB 24787-2009 "Disposable Non-sterilized Rubber Surgical Gloves", and GB 24788-2009 "Limits for Residual Powder on the Surface of Medical Gloves and Water Extracted Protein" Requirements.

(2) Medical examination gloves

It should meet the requirements of GB 10213-2006 "Disposable Rubber Examination Gloves", GB 24786-2009 "Disposable Polyvinyl Chloride Medical Examination Gloves", and GB 24788-2009 "Limit of Residual Powder on the Surface of Medical Gloves and Water Extraction Protein" Requirements.

(3) Residual amount of ethylene oxide (if sterilized with ethylene oxide)

It should meet the relevant requirements in GB / T 16886.7-2001 "Medical Device Biological Evaluation Part 7 Ethylene Oxide Sterilization Residues"; if there are endotoxin requirements, it should also meet YY / T 0616-2007 "Single Use Relevant requirements in Biological Evaluation Requirements and Tests of Medical Gloves.

Our company provides a series of medical glove production line. If you have any demand for our products, please feel free to contact us.

Medical Making Machine Factory

How to Distinguish Medical/Non-Medical Gloves?

Basic classification of gloves

Medical making machine factory introduces: gloves can be divided into Medical gloves and non-medical gloves according to their USES.Medical gloves can be divided into surgical gloves and medical inspection gloves according to the applicable scene.

Surgical gloves: surgical operations such as various operations, central catheter catheterization, total parenteral nutrition fluid preparation and other use.

(2) medical inspection gloves: for direct or indirect contact with the patient's blood, body fluids, secretions, excreta and articles obviously contaminated by body fluids.

(3) non-medical gloves: in daily work (non-medical work) and life, some operations need hand protection, such as industrial manufacturing, cleaning labor protection, experimental chemistry, or some operations have health requirements, such as food processing.

two

Distinguish by appearance and packaging information

A: by appearance

The materials of medical gloves mainly include natural rubber gloves, nitrile rubber gloves, polyethylene (PE) gloves and polyvinyl chloride (PVC) gloves.There are many kinds of non-medical gloves, including cloth gloves and leather gloves.The four kinds of medical gloves with tax Numbers 3926201100, 3926201900, 4015110000 and 4015190,000 announced in the attachment of no. 53 announcement are made of plastic and rubber materials.If the glove is not made of these two materials, it can be considered as a non-medical glove.

B: by packaging information

Observe whether the words "surgical" or "medical" in English are included on the package information, and whether the medical application scenarios and medical USES are described.If there is relevant information, it can be judged as medical gloves.

three

According to the applicable standard of goods

Gloves can be classified as medical/non-medical according to the applicable standards indicated in the test report and certificate provided by the commodity packaging or manufacturer

A: to the United States

Medical gloves belong to medical devices in the United States, which are regulated by the United States food and drug administration (FDA). They can only be marketed in the United States after obtaining the factory registration and medical device listing through 510 (k) registration or other means recently announced by the FDA.

If the outer packaging of gloves or the manufacturer provides the testing report and certificate with FDA related information, or marks the applicable standards, the gloves can generally be judged as medical gloves.

Pay attention to

In 2016, the U.S. food and drug administration issued a final rule banning powder gloves, deciding to ban powder gloves from medical activities, including powder surgical gloves, inspection gloves, and surgical gloves used to lubricate absorbable powder.If powder gloves are not marked with fda-related information, they can be judged as non-medical gloves with high probability.

B: to the European union  

European union   medical/non-medical gloves are required to be covered with the CE mark, but the applicable standards are different.

Medical gloves belong to medical devices in the eu, and the CE mark shall be affixed in accordance with the eu medical device regulations 2017/745 / (MDR).The corresponding standard is EN 455-1 / en455-2 / en455-3 / en455-4. Gloves imported to the eu with the above contents on the outer packaging, test report and certificate are generally judged to be medical gloves.Non-medical gloves are governed by the European union   (EU) technical regulations 2016/425. The corresponding standards are EN374, EN388, EN407, EN420, etc.

four

Use government registration to control information differentiation

Since medical gloves are registered or controlled according to medical devices in most countries or regions, they can be further distinguished by relevant registration control information.

A: China

Medical gloves belong to class ii medical devices in China, which are registered and managed by the provincial drug regulatory department at the first level, and can be inquired through the access number of medical devices.

B: The U.S.

Gloves that have been approved by the FDA of the United States can be checked through their registration number on their official website.

C: the European union  

The export of eu medical gloves can be inquired about through an authorized notified body. The European union   has published a series of bodies authorized by the European union  's unified supervision and certification authority, also known as the NB agency, and granted each institution a unique four-digit code known as the announcement number.The application and issue of CE certificate shall be issued by the notice number body authorized by the corresponding regulations and instructions.

 

 Nitrile Rubber Gloves

Category and Function Of Disposable Gloves

In some industries with high frequency of glove replacement, it is usually recommended to use disposable gloves, which can not only avoid cross-infection, but also greatly save the replacement cost, such as medical industry, laboratory, food processing industry and other industries with high requirements on hygiene.Disposable gloves are gloves made of thin rubber sheets or films.Disposable gloves are usually made of two materials: latex gloves and nitrile gloves.

Nitrile Gloves equipment supplier to share with you：

Latex gloves, usually used in professional Settings, such as the operating room, laboratory, etc of health conditions to demand higher place, advantage is has certain elasticity, and more durable, but resist the corrosion of animal fat, not contact with animal fat easily corroded, more important is according to the statistics of 2% - 17% of the people will have different degrees of allergic to latex.Latex gloves are made of high quality natural latex with other additives by special powderless process. The products are non-toxic and harmless.With good tension, good adhesion, flexible use.

Disposable nitrile gloves are a kind of chemical synthetic materials, acrylonitrile and butadiene through special process treatment and formula improvement, permeability and comfort has been close to latex gloves, and do not produce any skin allergies.Nitrile gloves have been developed in recent years and can be cleaned to reach levels 100 and 1000.Disposable nitrile gloves are mostly powderless.Nitrile gloves, in addition to the characteristics of latex gloves, and latex gloves have been improved to address the shortcomings of the first resistance to animal fats and oils corrosion, and do not produce allergies.

Latex Gloves Production Line

Medical glove Gloves equipment reminds you: viruses and bacteria are everywhere, and prevention is the best way to reduce the risk of infection. Wearing a mask and washing hands frequently are crucial.Novel coronavirus has the characteristics of transmission by contact, and the fact that the virus was found on the door handle of the home of a pneumonia patient, it is even more obvious that it is necessary to pay attention to hand hygiene and wear disposable medical gloves.

Go out purchasing articles for daily use, or through the network platform to buy, can prevent access to the "outside" items, such as supermarket shopping carts, bags, Courier packing box, etc., and return to work after the need to contact even more things, such as the hard to avoid can ride public transportation, elevators, etc., these places are likely to be contact with patients or suspected patients, in the absence of conditions at any time to wash your hands, wear disposable gloves is the effective measure to reduce the risk of infection.

Often Wash Hands or Wear Gloves, How to do the Protection of Hand Skin?

Because of the work needs, the hands of medical staff frequently wash and disinfect hands, wear gloves for a long time, and become dry, rough, and cracked. It is distressing to see the full.

With the continuous spread of new coronary pneumonia, the number of confirmed cases of infection continues to rise. It is not just medical staff. As ordinary people, we also use the usual protective methods such as masks, gloves, hats, etc. Some damage to the skin is unavoidable.

How to pay attention to skin protection and care under the new crown epidemic? The latex gloves production line manufacturer shares for you:

First of all, as the time and frequency of people wearing gloves increase, the skin diseases caused by wearing gloves will increase accordingly.

Because the glove is completely sealed, the moisture is directly in the glove after being discharged from the skin. The long-term humid environment and the warmth of the skin body temperature can easily induce fungal infection.

The most common disease of skin fungal infection is hand ringworm, which manifests as itching and blisters between the fingers and palm skin.

Due to continuous scratching, skin flakes, erosions, and scabs can appear. The skin damage can start from the local area, gradually expand, and the center slightly improves, but the edges continue to expand outward, showing an arc or irregular shape.

At the beginning, only one hand may appear, and after a long time, it may spread to the other hand.

People who often need to wash their hands or wear gloves should pay attention to the following items:

1. Gloves must not be worn for a long time, and should be removed in time after contact with a potentially polluting environment;

2. Wash your hands in time after taking off your gloves, and use a dry towel to dry your skin after washing to keep it dry;

3. Pay attention to the skin care of your hands. You can use hand cream after washing your hands, especially in winter, to prevent skin cracking and fungi to enter after destroying the skin barrier.

Chinese Household Gloves Production Line China

Some patients can also induce eczema on their hands due to wearing gloves, mainly because:

1. The ingredients in latex gloves such as mercaptopropithiazole, epoxy resin, etc. are susceptible to skin sensitivity, and allergic contact dermatitis and eczema appear;

2. The sweating eczema is formed due to abnormal skin perspiration due to long-term wearing of gloves;

3. The formation of eczema due to long-term wet immersion of the skin. It manifests as symmetrical blisters, erythema, and itching of the hands, which can spread to the entire hands at the sides of the fingers and palms.

Hand eczema and hand ringworm are easily confused. Generally, hand symptom eczema is likely to be rash. If necessary, you can go to the general hospital dermatology department to do a fungal examination to confirm the diagnosis.

Attention should also be paid to the local care of the hands:

1. Those who are latex allergic can wear a layer of plastic gloves inside when they wear gloves, and take off in time after handling the pollutants

2. Pay attention to keeping the skin dry, and try to avoid alkaline irritating detergents such as soap when washing your hands;

3. Pay attention to the dryness of the finger joints when towels are used to dry hands. Normally, a mild moisturizer can be used to keep the skin moisturized.

How to protect the skin of the hands when washing or wearing gloves frequently in the case of new pneumonia?

In short, everyone should pay attention to other infections such as fungal infections in addition to the prevention of viral infections in special periods, because the skin barrier function is more likely to be infected with viruses after the fungal infection.

Therefore, everyone should pay attention to the above related matters when putting on and taking off gloves and cleaning the hands. We protect our hands and skin as well as part of the fight against the new crown epidemic. Our company provides high quality chinese household gloves production line china. If you have any questions about our products, please feel free to contact us

How to Choose Good Disposable Gloves?

There is an increasing demand for disposable gloves in the society, but there are many types of disposable gloves on the market. According to different materials, they can be generally divided into disposable plastic gloves, disposable nitrile gloves, disposable PVC gloves Disposable PE gloves, etc. However, the materials are different, and the use of the gloves is also different; many users do not know how to buy, so today counting machine exporter will give a brief introduction to the majority of users, hoping to help everyone.

1. Disposable PVC gloves

Before, many people chose PVC gloves because of its low price and cost savings. Later, because PVC cannot be degraded, it does not meet the national sustainable development strategy. In fact, people who know the industry know that PVC gloves will use plasticizers in the production process, so many Enterprises have abandoned PVC gloves, and the production of PVC gloves has been declining year by year. Therefore, Lanhuo Electronics does not recommend the use of PVC gloves.

2. Disposable latex gloves

Some food manufacturers pay more attention to the difficulty of wearing gloves, so they will choose latex gloves, because latex gloves are indeed easier to wear than food-grade nitrile gloves, but you must pay attention to the feelings of some employees at this time. Statistics show that the probability of allergy caused by latex gloves is about 11% -17.3%. Among them, the probability of female allergies is generally higher than that of men. In fact, this probability is quite high. Secondly, latex gloves are milky white or beige, and it is not easy to be mixed in food. Distinguish.

3. Disposable nitrile gloves

Therefore, blue-colored food-grade nitrile gloves are the best choice in the food industry. Why do you say that dark ones are the best choice? Because the dark color mixed into the food is easy to be found, it avoids the problem that the food is mixed with foreign matter. Secondly, it will not cause employee allergies and will not cause adverse effects on the human body.

Counting Machine

How to choose good disposable gloves? Latex gloves equipment exporter introduces you:

1. Look at the material: Disposable gloves are made of new polyethylene materials, which are non-toxic and tasteless, have good transparency, safety and hygiene, and can directly contact food. Don't choose the recycled material granules, the appearance is black, even dark, taste, and the hygiene is not up to standard.

2. Look at the appearance: the qualified seal is good, the water is not leaking, so in the face of greasy, water stains, the dye is not easy to break, and the toughness is strong, the pull is strong, and wearing it can protect our hands from oil.

3. Look at the thickness: The thickness of the disposable glove is directly related to the weight of a single glove. Generally speaking, the weight of a single glove is thick, and the thickness of a single glove is thin. Broken, the better the thickness, the higher the price. Such gloves have strong barrier properties, are not easy to break, and are more resistant to oil, water, and dirt.

4. Look at the size: choose your own size model, pay attention to the appropriateness of the actual size, in order to be more accurate, you can measure it before buying, generally the length from the middle finger to the wrist, and the width of the palm. It is much easier to choose the size of the glove according to the measured size, and it is convenient to choose the appropriate size. It can't be too long, too short, or too big. The common sizes are large, medium, and small. Choose according to your needs.

5. Look at the packaging: select the packaging that has the production license certification, hygienic test report, and can provide the test certificate; the outer packaging has the production date, shelf life, production batch number, manufacturer address, packaging glove weight, length, width, thickness, etc. Information, product safety.

6. Look at the manufacturer: Disposable gloves are produced in formal factories, generally with complete qualifications, workshop standards, and process production comply with industry standards. Do not choose small workshops and black factories. There is no guarantee for hygienic after-sales.

We are household gloves production line suppliers. The above are two important points to pay attention to when purchasing disposable gloves. I hope you can refer to the above when purchasing.