About Medical Gloves
Medical gloves are examples of personal protective equipment that are used to protect caregivers and patients from the spread of infection or illness during medical procedures and examinations.
Types of Medical Gloves
Medical gloves are disposable and include examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves).
Use examination gloves when your hands may touch someone else's body fluids (such as blood, respiratory secretions, vomit, urine or feces), certain hazardous drugs or some potentially contaminated items.
The primary purpose of surgical gloves is to act as a protective barrier to prevent the possible transmission of diseases between healthcare
professionals and patients during surgical procedures.
Due to the potential mutagenic, carcinogenic and teratogenic effects of occupational exposure to chemotherapy drugs, its essential to use chemotherapy gloves to protect employees at risk are those who are involved in the manufacture, preparation, handling and administration of these drugs.
The FDA Guidances for Medical Gloves
Medical gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification. FDA reviews these devices to ensure that performance criteria such as leak resistance, tear-resistance and biocompatibility are met.
US standards for medical gloves testing are as below:
ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
ASTM D3578 Specification for Rubber Examination Gloves
ASTM D5250 Specification for Poly (vinyl chloride) Gloves for Medical Application
ASTM D6319 Specification for Nitrile Examination Gloves for Medical Application
ASTM D6977 Specification for Polychloroprene Examination Gloves for Medical Application
ASTM D7198-05 Standard Specification for Disposable Embalming Gloves for Single-Use Applications
ASTM D7103-19 Standard Guide for Assessment of Medical Gloves
ASTM D6978 - 05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
CE Marking and Medical Gloves
The CE mark indicates that a product may be legally offered for sale in any country within the European Union. The sale of gloves in the EU requires that the product is marked with the CE-label. Medical gloves must comply with the medical device directive (MDD93/42/EEC). Starting May 2020 this will be changed to regulation MDR (EU) 2017/745 instead of a directive. To show compliance the medical gloves are currently tested according to several harmonized standards:
EN 455-1 - Medical gloves for single use – Part 1: Requirements and testing for freedom from holes
EN 455-2 - Medical gloves for single use – Part 2: Requirements and testing for physical properties.
EN 455-3: Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
EN 455-4: Medical gloves for single use – Part 4: Requirements and testing for shelf life determination.
So select appropriate gloves by checking the medical standards printed on the glove box.
Powdered vs. Non-Powdered Gloves
To facilitate donning of gloves, powders have been used as lubricants. You may come across powdered and non-powdered glove options. Powdered gloves feature cornstarch coatings, which make them easier to put on and prevents them from sticking together. According to FDA reports, the risks of powdered gloves in medical settings outweigh the benefits. The powder can cling to the wearer's skin, causing irritation, inflammation or allergic reactions. It can also cause surgical complications involving peritoneal adhesions, which are a type of bond between a person's organs. Though this can improve convenience, the FDA has banned powdered gloves for surgery and patient examination purposes. In most instances, a non-powdered glove is a preferable choice.
Sterile vs. Non-Sterile
Sterile medical gloves are acceptable for surgical purposes, so they must have the best possible AQL ratings. Sterile gloves must have a high-quality AQL level of 1.5 or lower. Examination gloves can have an AQL as high as 2.5, so sterile gloves can be considered even safer. Because their manufacture requires strict testing, and sterile gloves may have a higher price.