Different Standards and Regulations for Disposable Medical Gloves

Introduction:

Disposable medical gloves are essential in the healthcare industry, offering protection for both healthcare professionals and patients. However, it's crucial to understand that not all disposable medical gloves are created equal. Different standards and regulations govern the manufacture and use of disposable medical gloves, ensuring that they meet the appropriate safety and performance criteria. In this article, we will explore the different standards and regulations for disposable medical gloves and why they matter.

ASTM Standards for Disposable Medical Gloves:

ASTM International is a globally recognized leader in developing and delivering voluntary consensus standards. The organization has developed several standards for disposable medical gloves, including D3578 for latex gloves, D5250 for vinyl gloves, and D6319 for nitrile gloves. Each standard outlines the physical and performance requirements that must be met to ensure that the gloves provide the necessary level of protection for medical procedures.

FDA Regulations for Disposable Medical Gloves:

The U.S. Food and Drug Administration (FDA) is responsible for regulating medical devices, including disposable medical gloves. The FDA's Medical Glove Guidance Manual outlines the agency's recommendations for manufacturers to ensure that their products are safe and effective. Additionally, the Medical Device Reporting (MDR) regulation requires manufacturers and importers of medical devices, including disposable medical gloves, to report adverse events to the FDA.

CE Marking for Disposable Medical Gloves:

The CE mark is a mandatory conformity marking for products sold within the European Economic Area (EEA). It indicates that the product complies with the essential requirements of relevant European health, safety, and environmental protection legislation. Disposable medical gloves must comply with the Medical Devices Directive (MDD) or the European Medical Device Regulation (MDR) to receive the CE marking.

The major Standards for Disposable Medical Gloves:

ISO.

International Organization for Standardizations(ISO) regularly publish standards which are audited for compliances by sanctioning organizations called “Notified bodies”. The relevant rubber medical glove standards are developed by the ISO Technical Committee TC 45, Sub Committee SC 4.

ISO 11193:2020 – Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution.

ISO 10282:2014– Single-use sterile rubber surgical gloves

EN

European Norm certification indicates compliances with the European Quality System Regulation (QSR)

EN ISO 374-1: 2016, Protective gloves against dangerous chemicals and micro-organisms — Part 1: Terminology and performance requirements for chemical risks.

EN 374-2: 2014, Protective gloves against dangerous chemicals and micro-organisms –Part 2: Determination of resistance to penetration.

EN 374-3: 2003, Protective gloves against chemicals and micro-organisms – Part 3 Determination of resistance to permeation by chemicals. But it has been SUPERSEDED, WITHDRAWN, and substituted by EN 16523-1:2015.

EN 374-4: 2013, Protective gloves against chemicals and micro-organisms - Part 4: Determination of resistance to degradation by chemicals.

EN ISO 374-5: 2016, Protective gloves against dangerous chemicals and micro-organisms — Part 5: Terminology and performance requirements for micro-organisms risks (including viruses).EN 420: Describing general standards for protective gloves

EN 455: Medical Gloves for Single-use

EN 455-1: Specification for freedom of holes (barrier properties)

EN 455-2: Specification for physical properties

EN 455-3: Requirements and testing for biological evaluation (biological properties/labeling)

EN 455-4: Requirements and testing for shelf life determination

EN 1186: Materials and articles in contact with foodstuffs.

ASTM

ASTM for American Society for Testing and Materials. Non-profit organization that provides a forum for consumers, manufacturers, citizens, organizations, government representatives and academia, to meet and write standards for variety of products, services, and materials.

The FDA recognizes the ASTM standards and they are listed in the US Federal Register. Glove manufacturers must conform to the standards in order to meet the requirements by the FDA for the particular type(s) of medical gloves.

ASTM D3578 - Standard Specification for Rubber Examination Gloves.

ASTM D3577 - Standard Specification for Rubber Surgical Gloves.

ASTM D6978 - Standard test method that outlines the procedure for assessing the resistance of medical gloves to permeation by chemotherapy drugs.

ASTM D5250 - Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.

ASTM D6319 - Standard Specification for Nitrile Examination Gloves for Medical Application.

ASTM D6977 - Standard Specification for Polychloroprene Examination Gloves for Medical Application.

ASTM D6124 - Standard Test Method for Residual Powder on Medical Gloves.

Conclusion:

Different standards and regulations govern the manufacture and use of disposable medical gloves, ensuring that they meet the appropriate safety and performance criteria. Compliance with these standards and regulations is essential for the safety and well-being of healthcare professionals and patients. When selecting disposable medical gloves, it's crucial to consider the appropriate standards and regulations and choose gloves that provide the necessary level of protection for the procedure. Those single-use rubber gloves coming out of Fitone factories, have been testing rigorously and approved by third-party authoritative professional testing institutions. Connect our team free for the test reports right now if in need.