June 15, 2022 admin
Standards for gloves as recommended by experts
Medical gloves for infection control;
Medical gloves are an example of personal protective equipment that is used to protect the user and/or the patient during medical operations and exams against the transmission of infection or disease. One component of an infection-control approach is the use of medical gloves. Exam gloves, surgical gloves, and medical gloves for handling chemotherapeutic chemicals are all made of disposable material (chemotherapy gloves). The FDA classifies these gloves as Class I medical devices that need a 510(k) premarket notice. The FDA inspects these devices to make sure they meet performance standards including leak resistance, rip resistance, and biocompatibility. Medical gloves are made of a variety of polymers, including latex, nitrile rubber, polyvinyl chloride, and neoprene; they are either unpowdered or powdered with corn starch to make them simpler to put on the hands. Medical gloves are divided into two categories: examination and surgical. Surgical gloves are produced to a higher level and feature more exact sizing, accuracy, and sensitivity. Surgical gloves are normally sterile, whereas examination gloves are either sterile or non-sterile. Medical gloves are commonly used in chemical and biological laboratories, in addition to medicine. Medical gloves provide some minimal protection against corrosives and contaminants on the surface. They are, however, readily penetrated by solvents and other dangerous chemicals, and should not be worn for dishwashing or any other work that requires the gloved hand to be immersed in the solvent.
History behind the discovery of gloves:
When Johns Hopkins Hospital opened in 1889, Caroline Hampton became the principal nurse of the operating room. When she experienced a skin response to mercuric chloride, which was used for asepsis, in the winter of 1889 or 1890,” her soon-to-be husband, William Halsted, urged the Goodyear Rubber Company to make thin rubber gloves for her protection. At Johns Hopkins, Halsted began the use of sterilised medical gloves in 1894. These gloves can be used in a variety of clinical settings, including dealing with human waste and dental procedures.
Standard protocol for using gloves:
Before putting on sterile gloves, make sure your hands are clean. Make sure your gloves are the right size so you can wear them comfortably while doing all patient care tasks. Natural rubber latex, which is used in some medical gloves, might cause allergic reactions in some persons. The FDA requires manufacturers to list the materials used to build the gloves on the package labelling. If you or your patient are allergic to natural rubber latex, gloves made of alternative synthetic materials (such as PVC, nitrile, or polyurethane) should be used. Medical gloves can be punctured by sharp items. If your gloves shred or tear, replace them immediately. Wash your hands thoroughly with soap and water or an alcohol-based hand massage after removing the gloves. Medical gloves should never be reused.
Regulatory compliances for different types of gloves:
Patient examination gloves (commonly referred to as chemotherapy gloves) are medical gloves certified for commercialization with chemotherapy labelling claims. The current FDA-recognized consensus standard for patient examination gloves, or an equivalent test technique, should be satisfied by these gloves. For chemotherapy glove 510(k) submissions, we propose using the 510(k) format for examination gloves mentioned in Chapter 6. Permeation and penetration data based on real testing with chemotherapeutic medicines should also be included in the 510(k) application. Patient examination gloves are used during dental cleanings, fillings, and other dental treatments. These gloves should be able to withstand the rigours of a patient examination. In the labelling of gloves suited for dentistry, you may use the phrase “dental.” The phrase “dental” should always be used in conjunction with the term “patient inspection glove,” not in place of it. The thickness of microsurgery gloves is carefully reduced in some regions, notably at the fingertips. 510(k) submissions for microsurgery gloves that are thinner than the parameters of the FDA-recognized consensus standard for surgeon’s gloves have yet to be approved. Testing, like with all surgeon’s gloves, should show that it is safe and effective for the purposes for which it is intended.
Total safety with SafeMode gloves:
The use of examination gloves is part of the standard precautions to prevent medical staff from the transmission of infectious agents between patients. Gloves also protect the staff from infectious agents originating from patients. IMAEC MEDNTEK offers Safemode Examination gloves that are non-sterile, lightly powdered and for single use only. The gloves are ambidextrous and fully textured. They have excellent barrier properties and high tensile strength. Natural rubber latex is used to make it. Safemode gloves are lightly powdered polymer-coated gloves of good quality. It includes a textured palm and finger surface for better instrument grip. It is manufactured in exact accordance with ASTM D 3577-06 and EN 455 specifications. It’s anatomically designed to prevent tiredness during operation.
Reference:
- Guidance for Industry and FDA Staff. (n.d.). 92.
- Medical glove. (2022). In Wikipedia. https://en.wikipedia.org/w/index.php?title=Medical_glove&oldid=1085402633
- Wearing gloves in the hospital: MedlinePlus Medical Encyclopedia. (n.d.). Retrieved June 14, 2022, from https://medlineplus.gov/ency/patientinstructions/000452.htm