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General product and regulatory information only; this page is not medical advice and does not describe clinical procedures.
Short answer
A finger cot is a disposable covering for a single finger, used as a barrier between the wearer and what the finger touches. In the United States, FDA lists the “Finger Cot” under product code LZB as a Class I device, regulated under the examination glove regulation, 21 CFR 880.6250 (titled “Non-powdered patient examination glove”). When a cot is exempt from premarket notification, that exemption is subject to the limitations in 21 CFR 880.9. Cots made of or containing natural rubber also fall under the latex labeling rules in 21 CFR 801.437.
Definition and scope: what is a finger cot?
A finger cot (also called a finger stall) fits over one finger rather than the whole hand. It covers a single finger where a full glove is not used. That is the plain-language meaning behind the search “what is a finger cot”.
The regulatory meaning is narrower. FDA does not give finger cots their own regulation. The openFDA classification record for product code LZB names the device “Finger Cot”, assigns device class 1, medical specialty “General Hospital”, and points to regulation number 880.6250 (record checked 2026-10-30). That regulation is titled for the glove, so the cot is classified under the glove definition rather than under a heading of its own.
The glove definition in 21 CFR 880.6250(a) describes 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 words “or finger” are the reason a cot sits under this regulation.
How finger cots are regulated
Three points come straight from the regulation text and the FDA classification record (checked 2026-10-30).
- Class I (general controls). 21 CFR 880.6250(b) classifies the device as Class I. General controls are the baseline requirements that apply to all device classes; see Medical Device Amendments of 1976 for the legal background to device classes.
- 510(k) exemption. The same paragraph states that “when it is a finger cot”, the device is exempt from the premarket notification procedures in subpart E of part 807, “subject to the limitations in 880.9”. The exemption is written for cots specifically, not for every item under the glove regulation.
- Product code LZB. This is the code under which FDA files the finger cot. The record also shows the third-party review flag as “N”.
This is US regulatory status for the product category. It says nothing about the quality, size, material, or sterility of any particular cot on the market, and it is not a statement that any specific product meets a standard.
Finger cot versus examination glove: what the regulation says
Because both sit under 21 CFR 880.6250, the regulation is the cleanest sourced way to compare them. The table contains only what the regulation text itself says.
| Question | Finger cot | Patient examination glove |
|---|---|---|
| Regulation | 21 CFR 880.6250, product code LZB | 21 CFR 880.6250 |
| Device class | Class I (general controls) | Class I (general controls) |
| Stated purpose | Worn on the examiner’s finger to prevent contamination between patient and examiner | Worn on the examiner’s hand or finger for the same purpose |
| Premarket notification (510(k)) | Exempt by name in paragraph (b), subject to the limitations in 880.9 | Not covered by the finger-cot sentence in paragraph (b) |
The practical reading for supply staff: the regulation treats the cot as the same kind of barrier device as an examination glove, covering a smaller area. For glove material and fit questions, see glove compatibility charts and nitrile glove sizing.
Materials and the latex labeling rule
21 CFR 801.437 applies to devices, and their packaging or components, that contain natural rubber and contact the human body. It covers natural rubber latex, dry natural rubber, and synthetic latex or rubber that contains natural rubber. A finger cot falls under it only when it is made of, or contains, such material. A cot made without natural rubber is not subject to these statements.
For a cot that is covered, the rule sets out the following labeling checks (checked 2026-10-30).
- A device that contains natural rubber latex and contacts humans must carry, in bold, the statement “Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.” The rule places it on the labels, the principal display panel, and the outside and immediate packages.
- A device made of dry natural rubber carries the statement “This Product Contains Dry Natural Rubber.”
- Such devices “shall not contain the term ‘hypoallergenic’ on their labeling.”
- Powder counts as a contact route, because “such powder may carry natural rubber proteins.”
Where it matters for labs and clinics
These checks can be turned into a short receiving checklist for anyone who stocks cots. Each item traces to a rule above.
- Does the carton say whether the product contains natural rubber latex or dry natural rubber? If it does, the 801.437 statement should appear on the principal display panel and packages.
- Does a latex-containing product use the word “hypoallergenic” anywhere on its labeling? The rule prohibits that term for such devices.
- Is the product described as powdered? Regulation 880.6250 describes non-powdered gloves as including only residual powder from manufacturing, and 801.437 treats powder as a way natural rubber proteins can reach a person.
- Is the product listed by the supplier under finger cots, product code LZB, so it can be matched to FDA’s record?
These are label and record checks, not a quality assessment. For other low-risk supplies in the same practical category, see what a bandage is.
Common misunderstandings
“Exempt from 510(k)” does not mean unregulated
Class I general controls still apply, and the exemption is explicitly subject to the limitations in 21 CFR 880.9.
“Hypoallergenic” is not a safe shorthand on latex products
For devices covered by 801.437, the rule bars the term on the labeling rather than treating it as a selling point.
The glove regulation is not “the finger cot regulation”
The cot is classified under the glove regulation. Citing 880.6250 for a cot is correct; saying the regulation is titled “finger cot” is not.
The latex caution applies only to cots that contain natural rubber
The statements apply to devices that contain natural rubber. They do not apply to a cot that contains none.
Frequently asked questions
What is a finger cot?
A finger cot is a disposable single-finger covering that acts as a barrier. FDA classifies it as product code LZB, Class I, under 21 CFR 880.6250.
Is a finger cot a medical device?
Yes. FDA lists “Finger Cot” in its device classification database as a Class I device in the General Hospital specialty.
Does a finger cot need FDA 510(k) clearance?
21 CFR 880.6250(b) exempts finger cots from premarket notification, subject to the limitations in 21 CFR 880.9.
What must a latex finger cot say on its label?
If it contains natural rubber latex, 21 CFR 801.437 requires the bold caution statement about natural rubber latex and allergic reactions, and bars the term “hypoallergenic”.
Sources
- 21 CFR 880.6250, Non-powdered patient examination glove: law.cornell.edu/cfr/text/21/880.6250 (checked 2026-10-30).
- 21 CFR 801.437, User labeling for devices that contain natural rubber: law.cornell.edu/cfr/text/21/801.437 (checked 2026-10-30).
- openFDA device classification, product code LZB: api.fda.gov/device/classification.json?search=product_code:LZB (checked 2026-10-30; data last updated 2026-10-19).
