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Small Latex Gloves: Exam Glove Labels and Checks

What a small latex exam glove is, how FDA regulates it, and the label wording to check on the box, from 21 CFR 880.6250 and 801.437.

Written and maintained by CASRAI Editorial Board

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

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Small latex gloves are disposable natural rubber latex gloves sold in a small size, usually as patient examination gloves. In the United States they are regulated as medical devices, and the rules that apply to a small glove are the same ones that apply to every other size: what the glove is classed as, what the package must say about its materials, and what the label must say about natural rubber latex. This guide covers those points so that a buyer or clinic staff member can check a box of small latex exam gloves against the regulator’s wording. It does not repeat the size chart; for millimetre dimensions see the latex glove size chart.

Who uses them: clinic and hospital staff, dental and veterinary teams, laboratory workers and students who need a disposable hand barrier in a smaller fit.

What small latex exam gloves are

Under 21 CFR 880.6250, a non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. The regulation also states that the final finished glove includes only residual powder from manufacturing. The material is not part of that definition: latex, nitrile, vinyl and other materials can all be patient examination gloves, and “small” is only a size designation.

FDA classifies medical gloves as Class I reserved devices that require a 510(k) premarket notification. For the material itself, see what a latex glove is.

Latex medical, exam and examination gloves: the same product class

The phrases “latex medical gloves”, “medical latex gloves”, “exam latex gloves” and “latex examination gloves” all describe a natural rubber latex glove sold for medical use. The regulation’s term is “patient examination glove” (21 CFR 880.6250). “XL” or “extra large” latex gloves are the same product class at the other end of the size range. Because the regulatory description does not change with size, the checks below apply to every size.

What to check on a box of small latex gloves

Check What the source says Source
Device status Medical gloves are Class I reserved medical devices that require a 510(k) premarket notification. FDA, Medical Gloves
Materials stated Manufacturers must state the materials used on the package. FDA, Medical Gloves
Natural rubber latex caution Labeling for devices containing natural rubber latex that contacts humans must include, in bold print: “Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.” 21 CFR 801.437(d)
Dry natural rubber Labeling for devices containing dry natural rubber must include, in bold print: “This Product Contains Dry Natural Rubber.” 21 CFR 801.437(e)
The word “hypoallergenic” Devices that contain natural rubber that contacts humans must not use the term “hypoallergenic” on their labeling. 21 CFR 801.437(h)
Powder FDA finalized a ban on powdered gloves on December 19, 2016, citing airway inflammation and hypersensitivity risks. FDA, Medical Gloves

Read this as a label checklist: a box of latex exam gloves in any size should state its materials, carry the natural rubber latex caution, and should not call itself hypoallergenic.

Powdered and powder-free small gloves

FDA’s 2016 final ban on powdered gloves means powdered medical gloves are no longer a regular option for patient examination use. Under 21 CFR 880.6250, the final finished glove includes only residual powder from manufacturing. Searches for small powder-free latex gloves are therefore looking for the standard form of the product.

Choosing a size

Sizes such as extra small, small, medium, large and extra large are manufacturer designations printed on the box. The regulations cited here do not set what “small” means in millimetres, so compare the dimensions given for a particular product against the size chart rather than assuming one brand’s small equals another’s. For other glove types and their sizing, see types of gloves.

Non-latex glove materials

FDA names polyvinyl chloride (PVC, or vinyl), nitrile and polyurethane as examples of other synthetic medical glove materials. Our pages on latex allergy gloves, vinyl gloves and the nitrile, latex and vinyl comparison cover those materials. For the meaning of “not made with natural rubber latex” claims, see this explainer.

Common mistakes

  • Treating “small” as a fixed dimension; it is a manufacturer’s size name.
  • Reading “hypoallergenic” on a natural rubber latex glove as a safety claim; the regulation prohibits the term on such labeling.
  • Assuming a latex-free product from the glove’s appearance or colour; the material must be stated on the package.

Frequently asked questions

What are small latex gloves?

They are disposable natural rubber latex gloves in a small size, normally patient examination gloves, which 21 CFR 880.6250 describes as disposable devices worn on the examiner’s hand to prevent contamination between examiner and patient.

Are latex medical gloves regulated?

Yes. FDA regulates medical gloves as Class I reserved medical devices that require a 510(k) premarket notification.

Is there a difference between latex exam gloves and latex examination gloves?

No difference in product class is stated in the regulation; both refer to a patient examination glove made of natural rubber latex.

Are XL latex gloves different from small ones in how they are regulated?

The regulatory description and labeling requirements cited here are not size-specific.

Must latex gloves carry a warning?

Yes. Labeling for devices containing natural rubber latex that contacts humans must include, in bold print, the statement “Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.” (21 CFR 801.437(d)).

Which other materials are used for medical gloves?

FDA names PVC (vinyl), nitrile and polyurethane as examples of other synthetic materials.

Sources

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