1. Ask the problem

When choosing Latex or Nitrile medical gloves, customers are not only interested in thickness, size, color or cost. For hospitals, clinics, distributors and export businesses,  the standard and quality profile of the product is one of the important bases for evaluating the ability to meet the usage requirements and requirements of each market.

In fact, a set of glove profiles can simultaneously appear many terms such as EN 455, ASTM D3578, ASTM D6319, FDA 510(k), CE, EU MDR, ISO 13485, ISO 10993, and AQL. However, these terms do not have the same meaning and cannot be used interchangeably.

For example, EN 455 is a set of standards related to single-use medical gloves in Europe; ASTM D3578 and ASTM D6319 are commonly used technical standards for natural rubber and Nitrile examination gloves, respectively; while FDA 510(k) relates to medical device management requirements in the United States.  EU MDR is the European Union’s legal framework for medical devices, while CE is a sign of conformity with applicable legal requirements. In addition, ISO 13485 focuses on the quality management system of medical device manufacturing organizations, while ISO 10993 is used in biological assessment activities.

For the quality control of each batch of products, AQL has a different role. AQL is not a separate certification for gloves but is a component of the sampling method of testing by attributes. At the company, sampling testing is currently carried out in accordance with ISO 2859-1:1999, combined with the quality control criteria specified in the company’s quality control system. The application of the sampling method helps businesses to systematically assess the quality of each batch of products instead of inspecting the entire number of products.

Therefore, when evaluating a Latex or Nitrile glove product, customers should not rely solely on the number of “certificates” listed on the catalog. It is more important to determine what type the product is in, what purpose it is used for, what market it is sold in, what standard is applied, what version of the standard is used, and whether there is a proper test record to prove compliance.

Properly understanding the role of each standard and certification not only helps businesses choose the right product but also limits common mistakes, such as considering AQL as a certification, CE as a standard, or assuming that having ISO 13485 means that each product has been certified for quality.

In this article, we will analyze the common standards and requirements for Latex and Nitrile medical gloves in turn, and clarify  the meaning, scope of application, and how to check the profile of each type so that B2B customers have a basis for more accurate product evaluation.

2. EN 455 – Critical Standard Set for Disposable Medical Gloves

EN 455 is a set of European standards for single-use medical gloves. EN 455 is not a single “certificate” but a group of requirements divided into several parts.

2.1. Main parts of EN 455

• EN 455-1: requirements and test methods related to tightness, in particular the puncture resistance of gloves.
• EN 455-2: requirements for physical properties such as tensile strength and elongation, and requirements related to product performance.
• EN 455-3: biological evaluation, focusing on aspects related to materials, chemicals and the potential for biological impacts.
• EN 455-4: requirements related to the identification and demonstration of the shelf life of gloves.
• EN 455-5: the new edition focuses on chemical substances that can be extracted from gloves, which is particularly useful in the evaluation of substances that are likely to be associated with allergic reactions to contact.

3. ASTM – Technical Standard for Latex and Nitrile Gloves

ASTM International issues many technical standards related to gloves. Two common standards in the field of medical examination gloves are ASTM D3578 for Latex gloves and ASTM D6319 for Nitrile gloves.

3.1. ASTM D3578

ASTM D3578 specifies technical requirements for natural rubber (Latex) examination gloves. This standard is commonly used to evaluate properties such as size, physical properties, and quality-related requirements of gloves.

3.2. ASTM D6319

ASTM D6319 applies to Nitrile rubber examination gloves. This is an important technical standard when businesses supply gloves to markets or customers that require specifications according to ASTM.

ASTM and FDA are not two types of “equivalent” certificates. ASTM sets out technical requirements and test methods; the FDA is the regulatory agency of the United States. ASTM standards can be used as part of the technical basis in the compliance dossier, but it does not automatically mean that the product has been authorized for circulation by the FDA.

4. FDA 510(k) – Legal Requirements for Bringing Medical Gloves to the U.S. Market

In the United States, the FDA regulates medical gloves as medical devices. Many medical gloves are Class I but are still in the category that require 510(k) premarket notification before the product is placed on the market, depending on the type and intended use.

During the review process, the FDA can evaluate factors such as leak resistance, physical properties, and biocompatibility. Therefore, when a customer requests “FDA”, the business needs to determine exactly whether they need a 510(k) record, whether the product has been cleared, or only requires testing to an FDA-recognized standard.

The FDA has banned the circulation of powdered medical gloves within the scope of regulation. Therefore, when selling for the US market, businesses should not introduce powdered medical gloves.

5. CE and EU MDR – CE should not be called a standard

For medical gloves, one of the important legal frameworks is Regulation (EU) 2017/745 – Medical Device Regulation (EU MDR). Businesses need to carry out conformity assessments according to the applicable requirements. When the product fully meets the requirements, businesses can use the CE mark as prescribed.

CE is not a “quality certificate” in the usual sense. The CE dossier must be associated with the product, classification, conformity assessment, technical dossier and relevant legal requirements.

In addition, it is necessary to distinguish  between medical gloves and personal protective gloves (PPE). Gloves designed to protect the user from certain occupational risks may fall under the scope of Regulation (EU) 2016/425.

So, even though they are all “gloves”, the intended use of the product can determine a different set of legal requirements and applicable standards.

6. ISO 13485 – Quality Management Systems for Medical Devices

ISO 13485 is an international standard for quality management systems for organizations involved in medical devices. ISO 13485 is not a specific certification for a glove or a specific shipment.

The value of ISO 13485 lies in the system: process control, document management, supplier control, traceability, handling of non-conformities, corrective actions, and other quality management activities. Therefore, when evaluating a manufacturer, ISO 13485 is an important piece of information but still needs to be viewed along with specific product records and test results.

7. ISO 10993 – Biological Evaluation

ISO 10993 is a group of standards for biological evaluation of medical devices. The assessment is not simply “with ISO 10993, the product is absolutely safe”, but must be carried out based on the nature of the material, the level and duration of exposure to the body, the purpose of use and the risk assessment.

When viewing the test report, customers should check the correct standard, test part, product sample, test date and conclusion of the testing laboratory

8. ISO 9001 – Quality Management System

The company is currently applying a quality management system according to ISO 9001. This is an international standard for quality management systems, helping businesses build and control processes related to production activities, quality inspection, raw material management, suppliers, handling non-conforming products, and improvements.

For the production and supply of Latex and Nitrile gloves, ISO 9001 is one of the bases that demonstrates the quality management system of the enterprise which is organized and controlled according to a unified framework.

Note: ISO 9001 is a certification of  the quality management system of the enterprise, not a separate certification for each type of glove or each batch of products

9. ISO 22000 – Food Safety Management System

The company currently applies a food safety management system in accordance with ISO 22000. This standard focuses on the identification, assessment and control of food safety-related hazards within the scope of certified operations.

For businesses that provide gloves for  the food processing industry, food production, restaurants, industrial kitchens and fields with high hygiene requirements, ISO 22000 is a significant content in demonstrating the capacity of enterprises to manage and control food safety.

Note: ISO 22000 is a certification of a food safety management system, which does not mean that all gloves are automatically allowed to come into contact with all types of food. The use of gloves in the food sector still needs to be based on the material, intended use, legal requirements and appropriate test records.

10. AQL – Important Indicators but Not Certificates

AQL (Acceptable Quality Limit) is an indicator that is often used when evaluating the quality of gloves, especially in checking for defects such as pinholes.

However, AQL is not a “quality certificate”, nor should it be simply understood as “the percentage of defective gloves allowed”.

AQL is associated with the sampling method and acceptance criteria of an inspection plan. When customers request AQL 1.5 or AQL 0.65, enterprises need to clearly define  the sampling standards, batch sizes, sample sizes, inspection levels and applicable acceptance criteria.

11. Summary table

Name	Nature	Main purpose
EN 455	Standard Set	Disposable Medical Gloves in Europe
ASTM D3578	Technical Standard System	Natural Latex/Latex Examination Gloves
ASTM D6319	Technical Standard System	Nitrile Examination Gloves
FDA 510(k)	Legal Requirements	Introduction of a wide range of medical gloves to the US market
EU MDR	Legal Framework	Medical devices in the European Union
CE	Signs of conformity	Demonstrate conformity with applicable EU law
EU PPE 2016/425	Legal Framework	PPE Purpose Gloves
ISO 13485	Management System	Quality Management in the Medical Device Field
ISO 9001	Management System	General quality management of the organization
ISO 22000	Management System	Food Safety Management
ISO 10993	Standard Group	Medical Device Biological Evaluation
AQL	Sampling methods/criteria	Quality control according to sampling plan

 

12. Conclusion

For Latex and Nitrile medical gloves, EN 455, ASTM, FDA 510(k), CE/EU MDR, ISO 13485, ISO 10993, and AQL play different roles.

• EN 455 and ASTM mainly provide technical requirements or methods;
• FDA and EU MDR related to the market management framework;
• CE is a sign of conformity;
• ISO 13485 focuses on quality management systems;
• ISO 10993 relates to biological evaluation;
• AQL is a concept in quality control and sampling.

13. Frequently Asked Questions

13.1. Is EN 455 a certificate?

Nope. EN 455 is a set of standards applicable to medical gloves, consisting of several parts with different requirements.

Therefore, businesses should describe products as being tested or evaluated according to the applicable EN 455 requirements, rather than calling EN 455 a single certificate.

13.2. What is the difference between ASTM D3578 and ASTM D6319?

D3578 generally applies to Latex gloves, while D6319 applies to Nitrile gloves.

13.3. Is FDA 510(k) the same as ASTM certification?

Nope. ASTM is the technical standards system; the FDA is the regulatory body. 510(k) is a pre-market notification mechanism for devices for products that fall under the scope of application.

Does 13.4. ISO 13485 prove a pair of quality gloves?

ISO 13485 mainly demonstrates that an organization’s quality management system is evaluated according to the scope of certification. The quality and suitability of each product still need to be demonstrated by proper product records and testing.