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Malaysia OEM Nitrile Cleanroom Gloves, Private Label For Medical, Pharmaceutical, Biochemical, Laboratory, Engineering & Electronics, FDA & CE Approved

RM31.00
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Minimum Purchase:
200 units

Private Label Nitrile Cleanroom Gloves at competitive price. Low Order Minimum of just 200 boxes/order.

Looking for a private label manufacturer to create your custom branded cleanroom gloves? Many may think that all disposable gloves are created equal, but that’s simply not the case. In fact, disposable gloves are available in a variety of options, each made with their own distinct purposes in mind. Procuring the incorrect type of glove for your intended application could damage materials and equipment, which is too costly a mistake for any company to make.

What Is a Cleanroom Environment?

Work areas that must remain free from contaminants like dust are known as clean environments (AKA Cleanrooms, or Controlled Environments). It’s also critical for these spaces to be free of other pollutants, including chemical vapors, aerosol particles, airborne microbes, and even static electricity. 

Most often, these special locations are found within companies that manufacture electronic components, as intricate and sensitive parts such as microchips could become compromised if exposed to any contaminants. Other industries in which cleanrooms are used include pharmaceuticals, scientific research, and aerospace semiconductor engineering.

What Is a Cleanroom Glove?

Cleanroom gloves look a lot like exam gloves.  They’re available in nitrile, latex or vinyl materials.  They’re thin, ambidextrous and disposable. To understand cleanroom gloves, we need to understand why they are needed.  

In “dirty” manufacturing environments, gloves are typically worn to protect the wearer from hazards in the environment such as chemicals, extreme heat/cold, and rough or sharp surfaces that could cause hand abrasions. In “clean” manufacturing settings such as cleanrooms and other controlled environments, gloves are typically worn to protect the product or process from contamination and are used along with cleanroom gowns, masks and other process protection apparel. Therefore, unlike in a dirty manufacturing environment, where users must identify hazards to human health and safety, in a cleanroom environment, it’s important to analyze hazards and risks to the process or product – the critical control points for contamination by personnel. 

Consider how dirty a “clean” environment might become due to human contamination: 

  • Even when stationary, people generate about 100,000 particles of 0.3 microns or greater. On the move, this rises to about 5 million. 
  • Every square inch of the human body has an average of 32 million bacteria on it. 
  • Every minute of the day, we lose about 30,000 to 40,000 dead skin cells off the surface of our skin. 
  • One square inch of hand surface area has an average of 10,000 microorganisms. 

Hence hazard analysis and risk assessment is imperative to understand the cleanroom environment and the allowable levels of particulates, extractables and nonvolatile residues (NVR). 

For sterile/aseptic cleanrooms, the hazard analysis and risk assessment process should focus not only on particulate control but also on microbiological control. Every cleanroom in every industry is different. 

  • Medical Device manufacturers may operate at ISO Level 8 for raw material processing, ISO Level 7 for assembly and packaging and ISO Level 5 for aseptic assembly and QC testing for sterility. 
  • Pharmaceutical manufacturers may operate at ISO Level 5 for sterile filtration and aseptic filling/stoppering; ISO Level 7 for solid dose granulation, blending, compression, and coating or aseptic compounding; and ISO Level 8 for solid dose packaging and cleaning, sterile materials staging, and sterile capping, labeling and packaging.

Glove Materials 

Cleanroom gloves are typically made from vinyl, natural rubber latex, nitrile or chloroprene. We outline advantages and disadvantages of each: 

  • Vinyl - known for being very clean, inexpensive and static dissipative. However, vinyl gloves retain heat and have poor moisture vapor transmission. 
  • Natural Rubber Latex - has the best cost/performance ratio of any material available. It is durable and easy to manufacture. However, it has no inherent static dissipative features. Some people have allergies to the proteins found in natural latex, which can result in painful rashes. 
  • Nitrile - offers very good puncture resistance and exhibits broader chemical resistance than that of natural latex, especially with solvents. Nitrile also has very good static dissipative features not found in natural rubber latex. 
  • Chloroprene – is not widely used in the cleanroom industry, but has characteristics similar to those of nitrile. 

A glove’s material can have a dramatic influence on its comfort. For example, latex gloves are typically viewed as being more comfortable, while vinyl gloves tend to be more uncomfortable due to the rigid nature of vinyl. Nitrile gloves are now becoming more comfortable, however. 

Glove Selection for Controlled Environments

There are a variety of factors that must be taken into account when you are selecting cleanroom gloves for private labeling.

1. Performance Certification & Compliance

In cleanrooms, a glove’s particle and extractable counts are important and should be closely evaluated to match the cleanroom class. Compliance with AAMI, ASTM, and EN standards and regulations is prerequisite.

In the pharmacy industry, compliance with USP (797) is also important. Because the cleanroom gowning process is so strict and time-intensive, it’s important for gloves to stand up to the gowning process itself, as well as work tasks within the cleanroom to avoid having to exit the cleanroom for re-gowning if the glove tears or has defects. Therefore, durability and strength are two important factors to consider as is barrier integrity (freedom from pinholes), especially for sterile cleanroom gloves. 

Some cleanroom environments are sensitive to static electricity, so gloves should be evaluated for electrostatic discharge (ESD) resistance properties. Other cleanroom environments are concerned with non-volatile residue (NVR), contamination that is not easily removed from surfaces through evaporation. Gloves for these environments should be evaluated to ensure they do not contain NVR. 

Superior performance is of utmost importance in the cleanroom environment. Ensure the clean room glove you choose to private label is not only of the highest quality, but that it also stays within a reasonable variance of that level over time. 

Lot consistency should be ensured from raw materials through processing. Acceptable Quality Level (AQL) is one piece of important data to consider. This refers to the probability of having defective gloves within a lot. The lower the AQL number, the lower the probability of defective gloves. 

While ASTM sets an AQL of 2.5, PrimeHub exceed that standard to provide gloves with fewer pinholes and thus, a greater level of barrier protection. Using new nitrile-based production technologies that combine the sensitivity of latex with the protection of nitrile, PrimeHub offer cleanroom gloves that provide the best of both worlds at a value price.

We provide certificates of analysis (COA) with particle counts, extractable counts and other important data for each lot of product; trend data; technical specification sheets; and certificates of irradiation (COI) if you procure our OEM clean room sterile gloves.

2. Comfortability

Comfort is also part of the performance equation. It’s common sense that when a glove is more comfortable (soft and stretchy like a “second skin”), users will be more likely to comply with wearing protocols. Some users may prefer the comfort of hand-specific gloves, which are made with an opposing thumb that minimizes hand fatigue, while others work well with ambidextrous gloves, which tend to be less expensive to manufacture. Most sterile cleanroom gloves are hand-specific. 

3. Tactile Sensitivity

The glove’s tack level is also important. In some cases, high-tack gloves are preferred because they make it easier to hold items without the items slipping. In other cases, a slick grip is preferred for easier donning and double-donning, a common practice in aseptic environments. The amount of texturing on a glove can vary from fully textured to fingertip texture. Fully textured gloves are important with ambidextrous styles so that, no matter which glove is grabbed, the texture will be felt. Beaded cuffs are another important feature; they make the gloves easier to grip and pull up during donning.

4. Gloves Sizing

Sizing is an important comfort factor. While most suppliers offer a range of glove sizes, some are tweaking the formula to fit a wider variety of hand sizes – for example, offering larger-size gloves, hand-specific gloves, gloves with extra-wide palms, or extra-small sizes. 

The gloves’ length is another sizing issue to consider. As measured from the tip of the middle finger to the cuff, cleanroom gloves are either 10 inches or 12 inches. Ten-inch gloves are typically used in less stringent cleanroom environments, while 12-inch gloves are used in more stringent cleanroom environments in conjunction with cleanroom gowns. The longer gloves allow the gown sleeves to be tucked into the gloves, thus eliminating problems with gown sleeves billowing out as air moves past their cuffs, which creates a potential contamination concern as skin becomes exposed.

5. Packaging & Sterility 

Cleanroom design, operator procedures, correct cleaning and sanitization are critical when it comes to cleanrooms, but if incoming items are not controlled, cleaned and monitored, the contamination will walk right in. This call for special attention to how and where gloves are packaged. Are the gloves packaged in a cleanroom environment? Are they double-bagged with an additional case liner to ensure cleanliness? 

For a sterile environment, sterile gloves that are processed for cleanrooms (not surgical), are packaged in poly wallets and pouches and are also sterilized through gamma irradiation or other methods to reduce potential bioburden. Sterilization completely removes and/or destroys viable organisms, rendering them unable to reproduce. For aseptic cleanrooms, sterile gloves must be suitably packaged for aseptic donning (applying the gloves without breaking the sterile field). This is easier to do if the gloves come in packaging that opens properly. Sterile gloves should be packaged in poly pouches and wallets that open up so the left and right gloves are easily donnable. 

Why Us

When procuring OEM gloves for any given working environment, considerations must be made for health and safety standards, budget factors, and the changing needs of workers. This can make procuring the right OEM glove a complex process. PrimeHub range of OEM gloves are designed and manufactured with specific industry requirements in mind, making our private labelling simple and as straightforward as possible.

Our private label nitrile gloves range are continuously evolving to suit the rapidly shifting needs of each of the industries we cater to; which means that no matter the work environment, we have a solution. This makes us stand out from the crowd, giving us an edge over our competitors. PrimeHub have one of the industry’s broadest and deepest OEM nitrile glove ranges. 

All our private label gloves are manufactured under stringent quality assurance and control systems. Our OEM gloves have earned quality recognition with CE markings and are compliant with various international standards. They are tested to FDA 510(K), EN 374, EN 455 and ASTM D 6319. 

Still need convincing? Want to know why choose us among other competitors or why keep on considering us your trusted OEM supplier? We give you whole range of reasons to do it. 

1. We Custom Made Nitrile Gloves to your Exact Specifications

If you are looking at customizing gloves for a specific market need, we have a team of technical designers to co-create with you. Our designers always stay on top of component material innovations. 

Whether they are specialty gloves with high puncture resistance, low weight gloves that are price competitive but maintain good quality, black nitrile gloves that are chemical resistant  or long cuff nitrile gloves for extra protection from high risk environments, our technical designers know which materials and constructions make these gloves fit and feel right. Customizing gloves to suit your specifications is what our technical designers do best! 

Powdered to powder-free, sterile and non sterile, finger textured to smooth surface, from blue gloves to green and orange, purple to black and white gloves, we tailor made the perfect gloves for every market and  end-application, from the broad based and volume driven medical markets to the niche industrial and specialty markets. 

2. We Make Private Labelling, Easy. Our Glove, Your Brand!

With years of experience in this business, we can easily and fully customize glove packing to suit your business and branding needs. 

Our existing range of glove packing can be easily modified to match your brand colors. We can also add your corporate logo to our ranges for a premium quality look. If you need to further distinguish your brand from our other OEM ranges, we can make design modifications.

Our whole glove range is available for private labelling, so just get in touch to start the process.

3. Gloves at the Right Price Point

Headquartered in Malaysia, the heart of the largest rubber producing region in the world and having direct access to key suppliers and technology, we are able to offer our customers superior gloves products at competitive prices. 

Specializing in OEM and private labels for the export market, backed by years of experience and immense market knowledge, we can help you to tailor make your gloves to your requirements at an efficient lower cost to receive higher profit margin. 

4. We're Trusted By Private Label Owners Worldwide

Our promise of quality, on time delivery, innovation and cost-effectiveness have made us a sought-after OEM glove supplier for many famous global private labels. 

Our export markets include high quality demand countries such as Japan, Singapore, USA, New Zealand, Hong Kong, United Kingdom, Switzerland, Eastern Europe, UAE and many others. 

5. Shipping & Delivery

We partner with different established freight forwarders. We provide our customers with the most competitive shipping and insurance rates, shortest possible delivery time, and flexibility in shipping liner selection, while keeping to our customers’ choice of handling modes.

6. Low Minimums

Been turned away from other OEM,  private label or custom made manufacturers because they won't take on your project due to low quantities? We start custom ordering at a lower minimum boxes per order.