Sterile Vs Non Sterile Gloves

24

Sep

With the ongoing pandemic, sterile & non-sterile gloves have become a necessity in every aspect of life.

These mandating necessities keep your hands safe from various harmful elements. Whether you need protection from harmful chemicals, sharp instruments, or dangerous microbes, gloves play a key role in keeping you safe in most industrial aspects.

The type of gloves you need to use and the role of gloves keeps varying, based on the following factors:

  • Purpose
  • Type of use
  • Nature of the product
  • The industry involved in such as healthcare, cleaning, food, movers and packers

That is, you cannot use thermal wear gloves while working in the healthcare industry.

Neither can you opt for the latex ones while serving hot dishes?

The healthcare sector is the most prominent industry where gloves are an absolute must.

Here, you will come across disposable gloves categorized into two main types — Non-Sterile disposable gloves and Sterile disposable gloves.

However, it is not easy to distinguish non-sterile gloves from sterile ones as they look the same.

Not sure which glove is the right choice, and what is the difference between sterile disposable gloves and those that aren’t?

We will uncover these primary concerns through this guide and find which one is best suited for which environment.

Difference Between Non-Sterile And Sterile Disposable Gloves

FDA’s SAL (standard assurance level) plays a primary role in differentiating between sterile and non-sterile gloves based on various mandated Sterilization techniques.

Sterile gloves must get approval for surgical use by undergoing sterilization procedures with radiation or ethylene oxide set by the FDA.

Once the FDA approves the gloves, they are considered completely sterile and devoid of any microbes.

Non-sterile gloves are not sterilized by the manufacturer but must undergo numerous sterilization techniques to be considered safe to use.

The FDA must also test them to ensure they have been sterilized and adhere to the FDA’s standard assurance level. However, they are not completely devoid of microbes, making them unfit to use for surgical procedures.

Other Differences

Some of the other differences between the sterile and non-sterile disposable gloves are:

Based On Usage

Sterile gloves are primarily used in medical environments to conduct surgical procedures to avoid cross-contamination risks.

Meanwhile, non-sterile medical-grade gloves are commonly used for medical examinations that do not pose a high threat of infection.

It is also suitable for non-surgical environments as a barrier against parasites, bodily fluids, and bacteria (1).

Based On AQL

Another major difference between these two gloves is the acceptable quality level of pinholes in a certain percentage of gloves.

Sterile surgical grade gloves must have a lower AQL than the non-sterile ones.

The FDA standard of AQL level for sterile gloves must be between 1.0 – 1.5, which indicates only 1% – 1.5% of the gloves in the set have pinholes.

Whereas non-sterile gloves have an AQL that ranges between 1.5 – 2.5, this means around 2.5% of these gloves may have pinholes.

Pricing

Due to the complicated sterilization techniques and strict manufacturing procedures set by the FDA, sterilized gloves are costlier than non-sterile options.

For instance, a sterile surgical glove box that contains 25 pairs costs around $30.

Whereas a non-sterile glove package of 100 pairs does not cost more than $5, making it a preferred choice for general safety purposes.

Packaging

Sterile surgical gloves must be individually packaged to ensure utmost safety.

Also, it requires special skills to open the package and remove the sterilized gloves properly, without contaminating them. However, individually wrapped packing is not required for non-sterile gloves.

Sterile Vs. Non-Sterile Disposable Gloves Applications

The main purpose is to prevent surgical site infections and provide hand hygiene while performing invasive surgical procedures.

The situations where sterile disposable gloves are usually used:

  • To perform dialysis.
  • While delivering babies.
  • To change dressings for surgical or operation wounds.
  • To perform invasive operation procedures.
  • To handle sterile surgical equipment in the operation theatre.

Meanwhile, non-sterile gloves have numerous applications, especially in the food industry, where the transfer of microbes needs to be kept to a strict minimum (2).

It’s also effective in protecting factory workers in chemical industries against acid spills, oily substances, and other harmful liquids.

The standard applications of these non-sterile gloves include:

  • Handle toxic materials in factories or chemical procedures.
  • Perform non-invasive medical procedures.
  • Give an injection.
  • Do medical examinations.
  • Perform dental procedures.
  • Prepare ready-to-eat food.
  • Dress up a wound using secondary intention

These gloves types are available in the market using different materials like latex, nitrile, or vinyl.

Nitrile gloves are the preferred option for those who are allergic to natural rubber.

Though vinyl is much cheaper, it poses a higher risk if torn or punctured.

Now that we know the differences and applications let’s look at each of these glove types in detail.

Sterile Disposable Gloves: What do you need to know?

Sterile gloves are the ones that comply with the sterilization techniques set by the FDA regulations.

Using these medical gloves can avoid cross-contamination between the caregivers and the patients and remain well-protected against deadly microbes and harmful chemicals.

As per the recommendations of the World Health Organization and the Center for Disease Control, it’s essential for any person working in the healthcare sector, including caregivers and healthcare workers — to wear personal protective equipment (PPE) like sterile disposable gloves to reduce the spread of diseases and contamination risks.

While placing an order for medical-grade sterile gloves, choosing the right ones is crucial based on your specific needs.

It is a must for medical professionals to use sterile gloves while performing any surgical procedures.

Orthopedic surgeons and oral surgeons solely use sterile medical disposable gloves packaged individually to maintain high sterility.

The other medical procedures where these gloves are a must include:

  • When preparing chemotherapeutic agents.
  • Performing invasive radiological procedures.
  • Conducting vascular access.
  • While preparing parenteral nutrition and much more.

The Need For Sterilization 

As sterile disposable gloves are exclusively approved by the FDA and mainly used for surgical procedures, they undergo many rigorous disinfection and sterilization protocols to eliminate the microbes, irritants, and debris.

The FDA does not permit any other type of gloves to be used during surgical procedures.

Using this pair during surgical protocols means healthcare professionals do not  need to worry about the iatrogenic transfer of foreign particles or exposure to bodily fluid and blood pathogens while performing the operative cases.

Some of the comments on sterilization techniques include:

  • High-pressure saturated steam.
  • Dry heat.
  • Ethylene oxide.

FDA Guide To Verify Sterile Gloves

As per the FDA standards, sterile gloves used by surgeons must be made using synthetic rubber.

Since medical personnel needs to keep their patients’ wounds from surgical site infections and contaminations, their medical equipment and gloves must be completely sterile during surgeries.

To begin with, before labeling and selling their products as sterile, manufacturers need to prove – the sterilization technique they used meets the FDA’s Standard Assurance Level (SAL).

In accordance with the FDA standards, they must conduct a massive amount of sterilization testing processes to guarantee medical-grade products.

These procedures are meticulous and rigorous, and the test requirements vary based on numerous factors, such as:

  • Incubation conditions.
  • Production materials and so on.

Before the sterile gloves can reach the market, the product must comply with the design requirements set by the FDA Quality System Regulation.

FDA Sterilization Standards 

The glove sterilization standards recognized by the FDA include:

  1. ANSI/AAMI/ISO 11135 – Sterilization control and validation of Ethylene oxide.
  2. AAMI/ISO – Contains technical information on sterilization of radiation and healthcare products.
  3. AAMI/CDV 11137 – Sterilization of healthcare products and radiation.

While conducting the sterility test, the product must have a SAL of 10^-6. When it comes to high-risk medical procedures where direct skin contact occurs during surgical cases, it is necessary to have a SAL of 10^− 3.

For gloves to be considered sterile, you also need to check the following:

Sterile disposable gloves must have a lower AQL (Accepted Quality Limit) compared with the non-sterile options.

As per the FDA standards, sterile gloves must have an AQL below 2.5.

When it comes to sterile surgical ones, the AQL level must not be above 1.5.

Once the sterilization procedure is complete, each of the gloves must be tested individually to ensure they adhere to the sterile glove criteria set up by the FDA sterility assurance level (SAL).

What does AQL mean?

The Accepted Quality Limit refers to the maximum number of defective gloves that are present in a batch.

When the amount of defective products goes beyond a certain AQL level, that batch of gloves is considered non-sterile and gets rejected.

A batch having 1.0 AQL will have up to 1% of their products being defective.

In comparison, a pack of gloves with 1.5 AQL will have a maximum of 1.5% gloves with pinholes.

As indicated earlier, sterile surgical gloves should have an AQL that ranges between 1.0 and 1.5. Similarly, sterile exam gloves having AQL levels between 1.5 and 2.5 will have defective glove samples that vary between 1.5% to 2.5%. 

Different Types of Sterile Medical Disposable Gloves and Their Uses

The medical-grade sterile disposable gloves are of two types:

  1. Sterile exam gloves: 

This type is mostly used to prepare pharmaceuticals, dental procedures, medical examinations, and minor surgeries that include potential bodily fluids and blood exposure.

Choices of these gloves used in healthcare include:

  • Sterile latex.
  • Synthetic latex-free nitrile.
  • Synthetic latex-free vinyl or PVC.

However, vinyl gloves are not much durable and have weaker protection against tough chemicals when compared with other materials. So, health workers are advised to avoid using vinyl gloves when handling chemotherapy drugs or coming in direct contact with bodily excretions.

  1. Sterile surgical gloves:

These gloves are designed to use while performing surgical treatments and procedures. Made using sterile latex, nitrile, or vinyl, they form a protective barrier against cross-contamination of pathogens. Sterile surgical gloves must also meet the following conditions:

  • Must be sterile and individually packed in pairs.
  • Has a very precise range of sizing.
  • Must adhere to the high level of quality standards set by the FDA

Purpose Of Using Medical Grades Sterile Gloves

Professional grade sterile gloves are mostly used for two purposes:

  1. To avoid the transmission and spread of deadly microbes into the environment due to the direct contact between (3):
  • Caregiver and the patient.
  • Healthcare worker and the patient.
  • Patient to patient.
  1. To reduce all possible chances of contamination risk when the healthcare personnel’s hands contact the patient’s bodily fluids and blood pathogens.

It is essential to use professional-grade sterile medical gloves while performing a complete body checkup and patient care.

A slight negligence in using the right type of gloves can result in the pathogens coming in contact with the caregivers’ skin through the microscopic tears and holes in the material or while removing the gloves.

Other Benefits Of Using Sterile Disposable Gloves 

Infection control: By donning this protective equipment, it helps create an effective barrier against potential pathogenic microbes, including deadly viruses and bacteria.

Prevention of communicable diseases: Using sterile latex disposable gloves prevents communicable diseases like AIDS, hepatitis B, HIV, and Hepatitis C.

Gloves are an essential part of controlling all types of infection. Hence you need to wash your hands well before and after using the gloves, especially if you encounter infectious materials.

Studies have found that washing hands using an alcohol-based solution will reduce the spread of contaminants to the surrounding surfaces, such as:

  • Electric switches.
  • Sinks, etc.

When To Wear Double-Gloving?

Are you a newcomer into the world of healthcare and not sure when sterile gloves must be worn?

It is a must to wear medical gloves when you come in contact with a bodily cavity, sterile tissue, or sterile spot.

It is an absolute must for almost any invasive contact and surgical intervention of the patient’s body.

As the delicate skin cannot be completely sanitized, the surgical personnel must use appropriate sterile equipment and sterilized disposable gloves.           

Double-Gloving

Finding it hard to handle the second gloves while donning the first pair of sterile medical gloves?

Wearing two sets of surgical sterile disposable gloves while performing invasive medical procedures is called the double gloving technique.

Healthcare professionals mainly use this method to reduce exposure to dangerous bloodborne pathogens. 

The glove that lies close to the skin and below the top one acts as an extra protective layer in case of any breaches during medical procedures and invasive surgical treatments.

Researchers have found that around 18% – 35% of sterile disposable gloves have miniature holes after surgical procedures.

Around 80% of the tiny puncture holes remain unnoticed by the surgeons.

To avoid Cross-contamination and exposure risks, double gloving has become a standard practice in surgical sites. 

Elements That Determine Barrier Protection

While donning gloves, other than the material, certain elements determine the amount of glove protection level. This includes:

  • Toxic chemicals that come in contact.
  • Proper fit of the gloves – poor-fitting gloves deliver little to no protection.
  • The time duration of using the gloves.
  • Handling abrasive equipment that can cause stress on the material.

Pointers To Know While Using Sterile Medical Gloves 

The following safety options must be noted before purchasing and while using sterile gloves to ensure the highest standards of patient safety and personal protection.

  • Opt for the right fitting gloves to help you to pick up surgical instruments easily without any discomfort. Choose the size that fits your hand properly to avoid any hindrances during patient care activities. These types of gloves are available in multiple sizes.
  • Remember to keep all the necessary medical supplies and tools ready and at hand before wearing the gloves.
  • Always wash your hands thoroughly before putting on the gloves and immediately after removal. After removing, you need to wash your hands well using soap and water or use an alcohol-based sanitizer to rub your hands.
  • Keep in mind that wearing sterilized gloves is not an alternative for proper protective hand-washing. Gloves must not be considered as a substitute for maintaining good hand hygiene.
  • As some patients are allergic to natural rubber latex, make sure to ask in advance if they’re allergic or opt for latex-free sterile gloves. The FDA regulations require the manufacturers to label the glove packages with the materials they have used.

Other Safety Measures

  • Never attempt to reuse sterile medical gloves. Avoid washing or disinfecting the sterile gloves with alcohol-based products for additional use.
  • Always remember to change your gloves after every medical procedure and after every patient contact. Never share your gloves with other individuals.
  • It’s advisable to avoid using powdered gloves in a healthcare environment. The cornstarch powder in the natural rubber latex contains protein allergens, and it can become airborne and cause irritation. Choose sterile powder-free disposable gloves as the next best alternative.
  • Be careful and pay careful attention while using sharp surgical objects to puncture holes on your sterile medical gloves. In case of any ripping or tearing, make sure to always change your gloves immediately.

Non-Sterile Disposable Gloves: What does it mean?

Non-sterile gloves must undergo numerous sterilization techniques set by the FDA to get rid of dangerous organisms and hazardous particles.

As per the FDA standards, it has an AQL rating that ranges between 1.5 to 2.5.

Though they are unsuitable for performing surgical and operative procedures, they are deemed fit for investigative procedures, medical examination, first aid, and other general purposes.

FDA Guide About Non-Sterile Gloves

Non-sterile gloves do not conform to the strict standards set by the sterility assurance level (SAL).

When it comes to non-surgical procedures like general medical examination, performing dental procedures, and a non-sterile glove is safe to use.

The commonly used non-sterile options are poly gloves, nitrile, or vinyl pairs. 

Some of the standards set by the FDA for the non-sterile disposable gloves include:

  • CAN 20.27-M91 – Suitable for both sterile and non-sterile medical examination gloves for only single-use purposes.
  • ADA Spec No. 102 – This is applicable for non-sterile nitrile disposable gloves used for dentistry.

Uses Of Non-Sterile Gloves

Non-disposable gloves are usually disposable and solely suitable for only single usage. These gloves are used for:

  • Medical examination of wounds and body cavities.
  • Conduct aseptic procedures.
  • First aid.
  • Handle laboratory specimens and equipment.
  • While coming in contact with surface residues and contaminants.
  • Handle biohazardous waste such as sputum, body fluids, feces, etc.

Non-Sterile Gloves – Safety Options

  • Non-sterile disposable clothes are not completely leaking or tear-proof, so they may contaminate your hands. Hence you must maintain hand hygiene each time you remove the gloves carefully.
  • Non-sterile gloves are suitable for single-patient use and must not be reused. Remember to remove it and carefully discard it after caring for a patient. Re-use of disposable gloves will result in the transmission of antibiotic-resistant microbes.
  • Make sure to remove or change your gloves while examining the contaminated site and later moving to a non-contaminated site on the same patient.
  • Non-sterile gloves are suitable for aseptic procedures such as contact with mucous membranes, body secretions, excretions, blood, body fluids, and even surfaces contaminated by bodily fluids.
  • Improper or indiscriminate glove usage, such as wearing gloves throughout the day, can result in the transmission and growth of pathogens.

Final Thoughts 

Sterile gloves have a specific spectrum of usage. Beyond the medical and surgical fields, they are not used anywhere else.

The main reason for this fixed margin of use is the higher cost of these disposable gloves.

Additionally, sterile gloves are FDA regulated and have very strict packaging and transporting mechanisms – which increases the cost of production.

On the other hand, non-sterile disposable gloves are much cheaper due to the easier packaging and transporting system.

Hence, it is widely used in various sectors such as the food and beverage industry, FirstAid, investigation processes, etc.

Both these types of gloves have their respective places and use in various sectors, and learning to understand their differences will enable you to utilize them to their full potential.

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