FAQs

What is a FDA 510K for gloves?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). The submitter may market the device immediately after 510(k) clearance is granted.

What is CE certification for gloves?

According to the definition of the European Commission, the CE marking is a “certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA)”.

What is ASTM D6319?

ASTM D6319 covers certain requirements for nitrile rubber gloves used in medical applications. Standard specifies various test methods including sterility testing, physical dimensions testing, physical requirements testing, powder residue, and powder limit testing.

Is ASTM D6319 the same as EN455?

Though ASTM D6319, ISO 11193, and EN 455-2 are very similar, EN455-2 is the most popular standard for testing the physical properties of medical gloves because of its specimen preparation requirements.

What does AQL 1.5 mean?

‘AQL’ stands for ‘Acceptance Quality Limit’, and is defined as the “quality level that is the worst tolerable” in ISO 2859-1. … For example: “AQL is 1.5%” means “I want no more than 1.5% defective items in the whole order quantity, on average over several production runs with that supplier”.

Is there a shortage of nitrile?

This far outpaced global production capacity, which in early 2020 could meet a demand for 370 billion gloves per year. In 2021, 50 billion additional gloves will be produced, but that still leaves a supply chain shortfall of 165 billion gloves.

Will the demand for gloves continue to increase or sustain after the current COVID-19 pandemic?

The worldwide growth in the healthcare industry is one of the key drivers for the rubber gloves industry. A rising consciousness and standard for hygiene, progressively stringent health regulations, prevention of chemical infections, etc. in the healthcare industry are some of the latest major factors contributing for an increased demand for gloves worldwide.

Is Malaysia the global leader in the manufacturing of rubber gloves ?

According to the latest figures, the demand leapt to about 360 billion pieces last year, pushing the annual growth rate to close to 20 per cent. Of the total output, Malaysia supplied about two-thirds, or 240 billion gloves. The estimated worldwide demand for this year ( 2020 ) stands at a massive 420 billion.

What Are Nitrile Gloves Made From?

Nitrile is a synthetic copolymer, formed through acrylonitrile and butadiene combining. The extra step of processing in the glove creation process was originally why when nitrile gloves first hit the market, they were so expensive compared to latex. However, technological advancements have lead to more cost-effective practices in the making of nitrile gloves. Nitrile gloves are now just as affordable as latex gloves.  Nitrile material also has a lower allergy rate than latex.

Are nitrile gloves chemo safe?

Glove material should be chosen according to the chemical characteristics of the drugs to be used, i.e. polarity, for maximum protection. For the majority of chemotherapydrugs, nitrile and natural rubber latex glove materials are preferable, while vinyl is inappropriate due to its generally increased permeability.

Are Nitrile Gloves BPA Free?

Nitrile Gloves are BPA free, Latex-free, Phthalate-free, Vinyl Free, MBT free and often powder-free.

What Do Nitrile Gloves Protect Against?

Nitrile Gloves protect the wearer’s hands. The nitrile material keeps the wears hands safe from any contamination, and they also stop the user from contaminating any item or surface that they are touching. Nitrile is waterproof, greaseproof, oil proof and most importantly, chemical resistant to a range of common chemicals and substances. Nitrile gloves are also commonly used in the medical industry due to their high puncture resistance, and dexterous strength.

Are Nitrile Gloves Impermeable?

It is important to remember nothing is impermeable forever. Nitrile material does have a higher chemical resistance rate than compared to latex material, although some chemicals will eventually pass through, especially strong grade chemicals. However, for an everyday work glove, nitrile gloves are a good choice for hand protection against common chemicals.

Are Nitrile Gloves Biodegradable?

Nitrile disposable gloves will eventually biodegrade. However, they do take longer to break down than latex disposable gloves.

Are Nitrile Gloves Hypoallergenic?

Nitrile Disposable gloves have a lower allergy rate than latex disposable gloves. Nitrile is the superior choice when it comes to people with allergies or sensitive skin.