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Glove Shortage: How to Check Whether It Is Real

How to tell if a glove shortage is real using FDA lists, and what to verify (510(k), Import Alert 80-04, labels) before switching gloves.

Written and maintained by CASRAI Editorial Board

Last updated

This page describes products and general use; it is not medical advice.

Short answer: a glove shortage is “official” only when FDA says so. FDA keeps a Device Shortage List and a separate Discontinuance List, and as of 1 November 2026 examination and surgical gloves are not on the shortage list. Two Cardinal Health nitrile examination glove items (sizes M and XL) appear on the Discontinuance List instead. This guide is for buyers, clinic and lab staff, and students who need to check whether a glove shortage is real and what to verify before switching products.

What a medical glove is

Per FDA, medical gloves are personal protective equipment used to protect the wearer and/or the patient from the spread of micro-organisms that may cause infection or illness during medical procedures and examinations. They are one part of an infection-control strategy, are disposable, and are used by clinic staff, laboratory staff and students in clinical placements.

Types of medical glove

Type Typical use Key regulatory point
Examination gloves Patient examinations and general procedures Class I reserved device; 510(k) required
Surgical gloves Surgical procedures Class I reserved device; 510(k) required
Chemotherapy gloves Handling chemotherapy agents Class I reserved device; 510(k) required

Source: FDA, Medical Gloves, checked 1 November 2026. FDA reviews these devices to confirm that performance criteria such as leak resistance, certain physical properties and biocompatibility are met. FDA requires the materials to be identified on the package labelling.

Safe use and handling basics

  • Medical gloves are made from different materials, including natural rubber latex, and FDA requires the materials to be identified on the package labelling.
  • Do not use powdered surgeon’s or powdered patient examination gloves; FDA banned them in a final rule published 19 December 2016 because of the risk of illness or injury.
  • Gloves are one part of infection control, not a replacement for the other parts of your facility’s procedures.

What counts as a glove shortage

Section 506J of the Federal Food, Drug, and Cosmetic Act requires FDA to maintain a publicly available, up-to-date list of the devices determined to be in shortage. FDA states that the presence of a device type on that list does not necessarily indicate that patient care has been affected. A separate list covers devices whose manufacturers have notified FDA that manufacturing is permanently discontinued. Both lists are managed by FDA’s Office of Supply Chain Resilience.

So three different things get called a “shortage”: a device type FDA has placed on its shortage list, a specific product being discontinued, and a distributor or manufacturer limiting quantities (allocation). They call for different responses.

Where to check glove status (and what it showed on 1 November 2026)

Signal What it tells you Glove status, 1 November 2026
FDA Device Shortage List (Section 506J) Device categories FDA has determined to be in shortage, organised by category and product code Examination and surgical gloves were not listed
FDA Discontinuance List Devices a manufacturer has told FDA it is permanently discontinuing Two entries: Cardinal Health “GLV EXAM PF NS NITRILE SIZE M” and “XL” (product code LZC, medical glove, specialty), dated 13 March 2026, discontinued and on allocation
Allocation FDA’s list describes it as limiting the quantity distributed to customers to extend the life of the existing supply Appears in the entry above

Source for all three rows: FDA, Medical Device Shortages List, page updated 26 October 2026, checked 1 November 2026. Re-check the list on the day you decide; it changes.

Nitrile glove shortage: what the official lists do and do not say

The only glove entries on FDA’s lists as of the date above are two nitrile examination glove items, and they are discontinuances of specific Cardinal Health products in sizes medium and extra large, not a listing of nitrile gloves as a category in shortage. If a supplier tells you “nitrile gloves are short,” compare that statement with the lists above, then ask which product, size and lot number is affected. For buying specifications that apply whichever supplier you use, see the nitrile gloves buying guide for the lab and the explainer on nitrile gloves.

Before you substitute a glove

A shortage of one product does not lower the regulatory floor for its replacement. Verify these points from FDA’s own pages:

  • Clearance. FDA regulates medical gloves as Class I reserved medical devices that require a 510(k) premarket notification. This covers examination, surgical and chemotherapy gloves.
  • Import status. FDA Import Alert 80-04 covers surveillance and detention without physical examination of surgeon’s and patient examination gloves. FDA states that defective medical gloves present a potential hazard to health for users as well as patients, and districts may detain without physical examination shipments from listed firms. A glove from an unfamiliar overseas maker should be checked against this list (page published 16 July 2026, checked 1 November 2026).
  • Powder. Powdered surgeon’s gloves and powdered patient examination gloves were banned by a final rule published 19 December 2016, so powdered stock is not a valid substitute.
  • Material labelling. Manufacturers must identify the materials on the package labelling, which shows what the glove is made of. Compare the label of the replacement with the one you are replacing.

Clinical decisions about which glove is acceptable for a given task belong to your clinicians and infection prevention committee; this page does not make them.

A shortage-response checklist

  1. Identify the exact product, size and lot affected, and who told you it is short.
  2. Check the FDA Device Shortage List and Discontinuance List and note the date you checked.
  3. Ask the supplier whether the item is discontinued, on allocation, or temporarily out of stock.
  4. For any substitute, request its 510(k) clearance information and confirm the maker is not subject to detention under Import Alert 80-04.
  5. Match the label materials, size range and the standard or quality level your own procedure requires, then record the change.

For wider planning, see hospital supply chain, including its section on shortages and discontinuances, and PPE stockpile and surge demand planning. For sourcing specifics, see wholesale nitrile gloves.

Common mistakes

  • Treating a supplier’s sold-out notice as an FDA-recognised shortage.
  • Assuming a listing means patient care has been affected; FDA says it does not necessarily.
  • Switching to an unfamiliar import without checking Import Alert 80-04 and the 510(k) status.
  • Using powdered gloves because they are available.
  • Changing materials without comparing the new label with the old one.

FAQ

Is there a glove shortage right now?

As of 1 November 2026, FDA’s Device Shortage List did not include examination or surgical gloves. Its Discontinuance List included two Cardinal Health nitrile examination glove items, sizes M and XL. Check the lists again before acting.

Is there a nitrile glove shortage?

FDA’s lists show specific nitrile glove discontinuances (13 March 2026), not a nitrile category shortage, as of the date above.

Which agency keeps the official list?

FDA, under Section 506J of the Federal Food, Drug, and Cosmetic Act, through its Office of Supply Chain Resilience.

Sources

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