What you need to know about nitrile gloves

When caring for suspected or COVID-19 patients, the CDC recommends that medical professionals use nonsterile disposable examination gloves. The question often lies in which glove material to choose. Considering that vinyl gloves are not very resistant to pathogens, the choice often lies between nitrile and latex gloves.

Nitrile vs. latex: which ones to choose

Gloves are usually made of either nitrile, latex, or vinyl. Vinyl and latex gloves are respectively produced out of PVC (polyvinyl chloride) and synthetic rubber.

Nitrile gloves offer several qualities that explain their success as the medical gloves of choice.

Nitrile gloves are well suited for those suffering from latex allergies. They are also more resistant to puncture, chemicals, and viruses than their natural rubber alternatives. They also have a long shelf life of up to 5 years.

On the downside, latex gloves provide a better touch sensitivity, are biodegradable, and generally cheaper than the latex-free gloves.

For medical-grade gloves, certification is paramount.

When choosing a nitrile glove, it is critical to understand the certification. The general usage will define if the glove has to be chemical resistant, puncture-resistant, or of industrial grade.

In Europe, the CE mark certifies the quality of the gloves. They fall into two different categories:

PPE Category III is a minimum requirement for personal protection. The gloves must pass the EC examination by a notified body.
Medical Device Gloves are self-certified and fall into the EN455 directive. They are self-certified and used mainly for patient protection.

Considering the appropriate level of CE certification is essential, depending on the potential level of chemical or biological risk. The Acceptable Quality Level (AQL) defines the standard for pinhole defects. The lower the AQL, the lower the chance for a pathogen to pass through the glove. An AQL of 1.5 is the minimum criteria to be considered for Category 2 Biological agents.

Several standards are used to assess the level of protection:-:

EN374-1:2003: Low Chemical Protection
EN374-2:2003: Micro-organism protection
EN374-3:2003: Protection from Harsh chemicals
EN421:2010: Protection from Radioactive particles
EN1149-5: Electrostatic properties
EN388:2003: Mechanical Hazards
EN407:2004: Thermal Hazards
EN511:2006: Protection against cold

With viruses such as the SRS-CoV-2, a glove with EN374-2 Level 3 designation, AQL of 0.65, should be considered.

In the US, the American Society for Testing and Materials (ASTM) developed standards for patient examination gloves.

ASTM D6319-19 defines the standard specification for nitrile Gloves for medical applications.

Gloves are considered a class 1 device. They somehow require an FDA 510K Clearance. To be noted that powdered gloves are not allowed in the ISA for medical purposes. For medical examinations, powder-free nitrile gloves a.

Other standards, such as ISO 16604:2004 and ASTM F1671-97b, may also be requested.

What type of nitrile gloves do we offer?

At HASHI Healthcare, we work with more than eight gloves factories located in Malaysia, Thailand, Vietnam, and China.

All of the certifications are carefully analyzed and follow the recommendations of the CDC. To know more about our procedures, please read our article about the current market for gloves.