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This page describes products and general use; it is not medical advice.
Gloves for health care are disposable medical gloves that the US FDA regulates as medical devices. This guide is for clinic staff, buyers and students who need to sort a glove need into the right category, know what the workplace rule (OSHA) expects, and know what to check on a package. It covers the regulatory and workplace frame; for material trade-offs and sizing it points to separate pages.
Who uses them: health care workers and others whose tasks involve hand contact with blood or other potentially infectious materials, mucous membranes or non-intact skin (the situations OSHA names in its bloodborne pathogens standard).
What counts as a health care glove?
The FDA’s medical gloves page says medical gloves are disposable and include “examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves)”. The FDA regulates them as Class I reserved medical devices that require a 510(k) premarket notification. In general, the FDA reviews whether performance criteria such as leak resistance, certain physical properties and biocompatibility are met (FDA, checked 2026-11-01).
The federal regulation for the most common type, the non-powdered patient examination glove (21 CFR 880.6250), defines it as “a disposable device intended for medical purposes” and classifies it as Class I (general controls) (eCFR, checked 2026-11-01).
Types of health care gloves
The FDA names three medical glove categories. For a deeper look at exam gloves versus surgeon’s gloves, see dental gloves: exam vs surgeon’s gloves.
| Category | How the FDA describes it | FDA regulatory status |
|---|---|---|
| Examination gloves | Disposable medical gloves; the non-powdered patient examination glove is defined in 21 CFR 880.6250 as a disposable device intended for medical purposes | Class I reserved device; 510(k) required |
| Surgical gloves | Listed by the FDA as a medical glove category | Class I reserved device; 510(k) required |
| Chemotherapy gloves | Medical gloves “for handling chemotherapy agents” | Class I reserved device; 510(k) required |
Sources: FDA, Medical Gloves; 21 CFR 880.6250. Both checked 2026-11-01.
When are gloves required in the workplace?
OSHA’s bloodborne pathogens standard, 29 CFR 1910.1030(d)(3)(ix), says gloves “shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin”. Gloves are also required for vascular access procedures (with exceptions listed in the standard) and “when handling or touching contaminated items or surfaces” (OSHA, checked 2026-11-01).
The same standard sets the employer duties around them: the employer provides personal protective equipment “at no cost to the employee”, and hypoallergenic gloves, glove liners, powderless gloves “or other similar alternatives shall be readily accessible” (1910.1030(d)(3)(i) and (iii)). For how gloves fit with the wider set of precautions, see standard precautions and infection control.
When must a glove be replaced?
OSHA states that disposable (single use) gloves, such as surgical or examination gloves, “shall be replaced as soon as practical when contaminated” and “as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised”. It also states that disposable gloves “shall not be washed or decontaminated for re-use” (1910.1030(d)(3)(ix)(A) and (B)).
What to check on a package: a selection checklist
Every item below comes from the FDA or OSHA text above; none is a ranking or a recommendation of a product.
- Which category does the task call for? Match the product to the FDA category it is listed under: examination, surgical or chemotherapy.
- Do the package labels state the materials? The FDA requires manufacturers to identify the materials used to make medical gloves on the package labeling. Materials named in FDA’s glove guidance include natural rubber latex and the synthetics polyvinyl chloride (PVC), nitrile and polyurethane. See nitrile vs latex vs vinyl gloves for the material comparison.
- Is the product powdered? On December 19, 2016, the FDA published a final rule banning powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.
- Is a non-latex or powderless option readily accessible to staff? OSHA requires hypoallergenic gloves, liners, powderless gloves or similar alternatives to be readily accessible.
- Is the device marketed as a medical glove? The FDA’s page describes medical gloves as devices that need a 510(k). For how to check FDA status, see FDA-compliant nitrile gloves.
Sizing and thickness are covered separately: nitrile glove sizing and nitrile glove thickness (mil).
Common mistakes
- Washing or decontaminating disposable gloves to reuse them. OSHA states they shall not be washed or decontaminated for re-use.
- Continuing with a torn or punctured glove. OSHA calls for replacement as soon as feasible when a glove is torn, punctured or its barrier function is compromised.
- Not offering alternatives. Hypoallergenic or powderless gloves are expected to be readily accessible.
- Assuming gloves are only for patient contact. The OSHA text also covers handling or touching contaminated items or surfaces.
FAQ
Are medical gloves regulated by the FDA?
Yes. The FDA regulates examination, surgical and chemotherapy gloves as Class I reserved medical devices that require a 510(k) premarket notification.
Are powdered medical gloves still allowed?
No for the devices named in the FDA’s final rule of December 19, 2016: powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove are banned.
Can single-use gloves be washed and reused?
No. OSHA’s bloodborne pathogens standard says disposable gloves shall not be washed or decontaminated for re-use.
Who pays for gloves at work?
Under 29 CFR 1910.1030(d)(3)(i), the employer provides the personal protective equipment at no cost to the employee.
Where can I find out what a glove is made of?
On the package labeling, which the FDA requires to identify the materials used.
For supply-shortage questions, see glove shortage: how to check whether it is real.
Sources
- FDA, Medical Gloves, checked 2026-11-01.
- OSHA, 29 CFR 1910.1030, Bloodborne pathogens, checked 2026-11-01.
- eCFR, 21 CFR 880.6250, Non-powdered patient examination glove, checked 2026-11-01.
