Written and maintained by CASRAI Editorial Board
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General product information from FDA and federal regulation text. It is not medical advice and does not tell anyone which product to use for a person’s care.
Overview: two ways to sort medical supplies
Medical supplies can be sorted on two separate axes. One is how the item is used: disposable items versus equipment built for repeated use. The other is regulatory risk: FDA assigns every generic type of device to Class I, II or III. The two axes do not line up, and the classes do not track how long an item lasts. The first step in any list of medical supplies is knowing which axis the list uses.
FDA has established classifications for approximately 1,700 different generic types of devices, and each generic type is assigned to one of three regulatory classes. “Class I includes devices with the lowest risk and Class III includes those with the greatest risk” (FDA, checked 2026-10-31). Medicare uses a different test for durable medical equipment (DME), set out in 42 CFR 414.202. This guide walks through both, with a table of example types whose class and definition come from the FDA classification database and the Code of Federal Regulations.
For a working list of what a physician office stocks, see medical supplies for a doctor’s office. This page explains how the categories themselves are defined.
Types table: what the regulation says each type is
Each row below is a generic device type. “What it is” paraphrases the identification paragraph of the cited regulation; “Class” is the class in FDA’s classification database for the product codes shown. Class is a property of the generic type, not of a brand.
| Type | What it is (21 CFR) | FDA class | Use pattern in the text | Limits of this row |
|---|---|---|---|---|
| Patient examination glove | A disposable device worn on the examiner’s hand or finger to prevent contamination between patient and examiner (880.6250) | Class I (general controls) | Described as disposable | The non-powdered glove entry is shown; other glove types have their own entries |
| Piston syringe | A calibrated hollow barrel and movable plunger with a nozzle that fits a hypodermic needle hub; used to inject fluids into, or withdraw fluids from, the body (880.5860) | Class II | The regulation does not say disposable or reusable | Product codes under this regulation differ in intended use |
| Clinical electronic thermometer | Measures body temperature with a transducer and electronic display unit; the probe may be detachable, with or without a disposable cover (880.2910) | Class II | Reusable unit; the cover is the disposable part | Exemption from premarket notification is set out in the regulation itself |
| Mechanical wheelchair | A manually operated device with wheels, intended for medical purposes to provide mobility to persons restricted to a sitting position (890.3850) | Class I (general controls) | Equipment type; see the DME test below | Whether a payer treats a given item as DME depends on that payer’s definition |
| Powered wheelchair | A battery-operated device with wheels for the same purpose (890.3860) | Class II | Equipment type; see the DME test below | Same as above |
| Liquid bandage | Product code KMF, “Bandage, Liquid”, under 880.5090 | Class I | Not stated in the database entry | The database entry carries no definition text |
| Chemical sterilizer | Product code MLR, “Sterilizer, Chemical”, under 880.6860 | Class II | Equipment for reprocessing | The database entry carries no definition text |
Two items on this list are the same kind of everyday supply yet sit in different classes: an examination glove is Class I, and a piston syringe is Class II. That is the practical reason a “types” list sorted by use cannot be read as a risk ranking.
How the setting changes the category
The setting changes which test applies, not what the item is.
Home care
For Medicare, equipment counts as durable medical equipment when it meets all five conditions in 42 CFR 414.202: it can withstand repeated use; for items classified as DME after January 1, 2012, it has an expected life of at least 3 years; it is primarily and customarily used to serve a medical purpose; it generally is not useful to a person without an illness or injury; and it is appropriate for use in the home. This is Medicare’s payment definition, not a universal one. The related durable medical equipment list and DME HCPCS codes guides cover how the category is used in billing.
Clinic, hospital and lab
FDA’s device definition does not depend on where the item is used. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act a device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” that meets one of the use tests in the statute, such as being intended for the diagnosis, cure, mitigation, treatment or prevention of disease. Because “in vitro reagent” is named in the definition, laboratory reagents can be devices as well as hardware.
What to check on the label
FDA tells manufacturers to define two statements for a product: its intended use, “the general purpose of the device or its function”, and its indications for use, which describe the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including the patient population. A product’s stated use is where its category is decided.
- The device name and intended use wording, which you can match to a generic type.
- The product code or regulation number, if shown, which you can look up in the classification database to see the class. Searching the database by device name leads to the classification regulation in the CFR. See how to use the FDA product classification database.
- Identifiers and symbols, covered in UDI production identifiers and the date of manufacture symbol.
Care and replacement
The federal texts cited here give two replacement signals. Regulations describe some items as disposable (the examination glove), and some devices carry a disposable part on a reusable unit (the thermometer probe cover). Medicare’s DME test uses an expected life of at least 3 years as one condition, so equipment is defined by long, repeated use. Cleaning, maintenance and replacement intervals for a specific product come from the manufacturer’s instructions for use for that product.
Glossary
- Medical device: an article meeting section 201(h) of the Federal Food, Drug, and Cosmetic Act.
- Generic type: a category of device, such as examination glove, to which FDA assigns a class.
- Class I: general controls. Class II: general controls and special controls. Class III: general controls and premarket approval.
- Durable medical equipment: Medicare’s five-part definition above.
- Intended use / indications for use: the two statements FDA asks a manufacturer to define.
FAQ
What are the main categories of medical supplies?
By use pattern, disposable items versus equipment for repeated use; by regulation, FDA Class I, II and III. A single item has a place on both axes, for example the examination glove is a disposable Class I device.
What counts as a medical consumable?
Federal regulations describe individual items as disposable, such as the examination glove in 21 CFR 880.6250, while Medicare separates DME, which must withstand repeated use, from other items.
Is a list of medical supplies the same as a risk ranking?
No. FDA class is set per generic device type based on risk, so two common supplies in one list can sit in different classes.
How do I find the class of a specific product?
Search the FDA product classification database by device name or product code; it leads to the classification regulation.
Sources
- FDA, Classify Your Medical Device, checked 2026-10-31.
- FDA, How to Determine if Your Product is a Medical Device, checked 2026-10-31.
- openFDA device classification API (api.fda.gov/device/classification.json), checked 2026-10-31.
- 21 CFR 880.6250, 880.5860, 880.2910, 890.3850, checked 2026-10-31.
- 42 CFR 414.202 (definition of durable medical equipment), checked 2026-10-31.
