Written and maintained by CASRAI Editorial Board
Last updated
General product information from FDA and eCFR sources, not medical advice. This page covers medical gloves (examination, surgical and chemotherapy-tested). Work, food-service, cut-resistant and fashion gloves are outside its scope.
Overview
Medical gloves fall into three groups: patient examination gloves, surgeon’s gloves and gloves tested for use with chemotherapy drugs. The FDA describes medical gloves as disposable and regulates them as Class I reserved medical devices that require a 510(k) premarket notification (FDA, Medical Gloves, checked 2026-10-30). In its review the FDA checks that performance criteria such as leak resistance, certain physical properties and biocompatibility are met, which is what the 510(k) clearance behind a marketed glove represents.
The type is set by the glove’s intended purpose, not by its material. Nitrile, latex, polyisoprene and other materials each appear across the groups, so the label matters more than the colour or the box.
Types of medical gloves: decision table
| Type | What it is (source wording) | Regulatory basis | What to look for |
|---|---|---|---|
| Patient examination glove | A disposable device worn on the examiner’s hand or finger “to prevent contamination between patient and examiner” | 21 CFR 880.6250; Class I (general controls) | Labelled as a patient examination glove; materials named on the package |
| Surgeon’s glove | A device worn by operating room personnel “to protect a surgical wound from contamination” | 21 CFR 878.4460; Class I (general controls) | Labelled as a surgeon’s glove; materials named on the package |
| Chemotherapy-tested glove | A medical glove for handling chemotherapy agents; FDA lists these as a third category of medical glove | FDA medical glove category; permeation practice ASTM D6978-05(2023) | A statement that the glove was tested to ASTM D6978, rather than an assumption based on material |
Both CFR definitions also say the finished glove includes only residual powder from manufacturing. The two definitions describe different purposes: the examination glove protects against contamination between patient and examiner, the surgeon’s glove protects a surgical wound. Those are the purposes the regulation states; this page does not go further than the text.
Powdered versus powder-free
For US medical gloves this is no longer a choice. On 19 December 2016 the FDA published a final rule banning powdered gloves (FDA, Medical Gloves, checked 2026-10-30).
Types of medical gloves by material
Material is a second axis, separate from type. The FDA requires manufacturers to identify on the package labeling the materials used to make a medical glove, for example natural rubber latex. For material-specific detail see our guides on nitrile gloves, latex gloves, polyisoprene and nitrile versus latex versus vinyl.
How the glove type is defined by purpose
The regulation classifies a glove by what it is intended to do, so the setting only matters through that purpose. The examination-glove definition is about preventing contamination between patient and examiner, the surgeon’s-glove definition is about protecting a surgical wound, and a chemotherapy claim is a test statement on the labeling. None of these regulatory definitions changes between a hospital, a clinic, a home-care visit or a laboratory; what the regulation looks at is the intended purpose printed on the box.
Laboratory and clinic work with blood or other potentially infectious material is also governed by OSHA’s bloodborne pathogens standard; our guide to PPE under 29 CFR 1910.1030(d)(3) sets out what that standard requires. Surgeon’s glove sizing is covered in our surgical glove size guide.
What to check on the label
- The glove type: examination, surgeon’s or chemotherapy-tested.
- The materials: the FDA requires them to be identified on the package.
- A chemotherapy test statement: ASTM D6978 is a practice that assesses breakthrough of nine chemotherapy drugs under continuous contact. CDC’s PPE-Info page describes it as a practice, not a glove specification (page updated 2024-02-21, checked 2026-10-30). A glove marked only as nitrile has not made that claim.
- No powder claim to rely on: powdered medical gloves are banned, so finished gloves carry only residual manufacturing powder.
Care and replacement
The FDA describes medical gloves as disposable. Storage conditions and shelf life are covered in our guide to storing gloves; follow the manufacturer’s instructions on the box for dating and storage.
FAQ
What are the types of medical gloves?
Examination gloves, surgical gloves and gloves for handling chemotherapy agents, according to the FDA. They are all disposable Class I reserved devices requiring a 510(k).
What is the difference between exam and surgical gloves?
The stated purposes differ. An examination glove prevents contamination between patient and examiner (21 CFR 880.6250); a surgeon’s glove is worn by operating room personnel to protect a surgical wound from contamination (21 CFR 878.4460).
Are chemotherapy gloves the same as ordinary nitrile gloves?
Not automatically. Chemotherapy-tested is a separate claim. ASTM D6978 is the permeation practice CDC lists for it, so look for that test statement rather than assuming it from the material.
Are powdered medical gloves still sold in the US?
The FDA published a final rule banning powdered gloves on 19 December 2016, so finished medical gloves carry only residual manufacturing powder.
Sources
- FDA, Medical Gloves, checked 2026-10-30.
- eCFR, 21 CFR 880.6250, Non-powdered patient examination glove, checked 2026-10-30.
- eCFR, 21 CFR 878.4460, Non-powdered surgeon’s glove, checked 2026-10-30.
- CDC PPE-Info, ASTM D6978-05(2023), checked 2026-10-30.
