Medical gloves are examples of personal protective equipment used to protect the wearer and/or the patient from the spread of micro-organisms that may potentially cause infection or illness during medical procedures and examinations. Medical gloves are one part of an infection-control strategy.
Medical gloves are disposable and include examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves). Medical gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification. Generally, the FDA reviews these devices to ensure that performance criteria, such as leak resistance, certain physical properties, and biocompatibility, are met.
On this page:
- When to use medical gloves
- What you should know before using medical gloves
- Ban on Powdered Gloves
- Additional Information
When to use medical gloves
Use medical 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.
What you should know before using medical gloves
- Wash your hands before putting on sterile medical gloves.
- Make sure your medical gloves fit properly for you to wear them comfortably during all patient care activities.
- Some people are allergic to the natural rubber latex used in some medical gloves. The FDA requires manufacturers to identify on the package labeling the materials used to make the medical gloves. If you are or your patient is allergic to natural rubber latex, you should choose medical gloves made from other synthetic materials (such as polyvinyl chloride (PVC), nitrile, or polyurethane).
- Be aware that sharp objects can puncture medical gloves.
- Always change your medical gloves if they rip or tear.
- After removing medical gloves, wash your hands thoroughly with soap and water or alcohol-based hand rub.
- Never reuse medical gloves.
- Never wash or disinfect medical gloves.
- Never share medical gloves with other users.
Ban on Powdered Gloves
On December 19, 2016, the FDA published a final rule banning powdered gloves (Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Gloves) based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body's immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications. For a detailed description of the risks that the FDA identified, please refer to the final rule.
- Medical Gloves for COVID-19
- Import Alert 80-04: Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves
- Import Alert 89-04 "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Medical Glove Guidance Manual - Guidance for Industry and FDA Staff
- FDA Consumer Update: Don't be Misled by "Latex Free" Claims
- Medical Device Bans
- Final Rule: Banned Devices: Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove