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A nit comb, also sold as a lice comb or lice removal comb, is a fine-toothed comb used to remove head lice and their eggs (nits) from hair. In the United States it is also a regulated medical device: FDA classifies “lice removal kit” combs as Class I under 21 CFR 880.5960. This guide explains what that classification covers and how the device family is identified. It is general product information, not medical advice.
Short answer
A nit comb is a comb or comb-like device intended to remove lice and nits from head and body hair. FDA regulates it as a Class I (general controls) device under 21 CFR 880.5960, product code LJL. (Checked 30 October 2026.)
Definition and scope
The federal regulation uses the term “lice removal kit” rather than “nit comb.” 21 CFR 880.5960(a) defines it as “a comb or comb-like device intended to remove and/or kill lice and nits from head and body hair,” and adds that it “may or may not be battery operated.” So the regulatory definition is wider than a plain manual comb: it covers any comb-like device with that intended use, powered or not.
Under 880.5960(b) the device is Class I (general controls) and is exempt from the premarket notification (510(k)) procedures in subpart E of part 807, subject to the limitations in 21 CFR 880.9. For background on how FDA sorts devices into classes, see the entry on the Medical Device Amendments of 1976, which created the three-class system, and on FDA De Novo classification, the route for novel devices with no predicate.
Types and related terms
Only two distinctions are made by the regulation itself, and the table keeps to those.
| Term | What the sources say |
|---|---|
| Nit comb / lice comb / lice removal comb | Everyday names for the same device family. FDA’s product code LJL is titled “Detectors And Removers, Lice, (Including Combs)” and maps to 21 CFR 880.5960 (openFDA, dataset updated 19 October 2026). |
| Manual comb | A comb-like device intended to remove lice and nits; within the 880.5960 definition. |
| Battery-operated comb | Also within the 880.5960 definition (“may or may not be battery operated”). |
Where it matters for labs, clinics and supply decisions
The classification record gives catalogue and compliance staff fixed identifiers to look up. openFDA lists product code LJL as device class 1, regulation number 880.5960, review panel HO (General Hospital), not an implant, not life-sustaining or life-supporting, with summary malfunction reporting marked “Eligible.” The same record shows the device is not flagged as exempt from good manufacturing practice requirements (gmp_exempt_flag N). Class I status means general controls apply; it does not mean a particular product has been tested for effectiveness. FDA’s Medical Device Reporting rules, explained in the entry on Medical Device Reporting (MDR), are the general framework for reporting device problems.
Manufacturers and distributors of devices in the United States are tied to the FDA registered establishment concept, and institutional buyers often purchase through a group purchasing organization (GPO). Because the code and regulation number are shared by all comb products in this family, a product listing that cites LJL or 880.5960 tells you the regulatory category, not the tooth spacing, material or performance. The regulation does not specify any of those.
Common misunderstandings
“The regulation sets the tooth spacing.”
21 CFR 880.5960 defines intended use only. It contains no tooth-spacing or material specification.
“Class I means FDA approved this product.”
Class I devices are subject to general controls, and this one is exempt from 510(k) premarket notification subject to 880.9. Exempt is not the same as individually reviewed.
FAQ
What is a nit comb?
A fine-toothed comb used to remove lice and nits from hair. FDA’s regulation calls the category a “lice removal kit”: a comb or comb-like device, battery operated or not, intended to remove and/or kill lice and nits from head and body hair.
What is a lice comb, and is it different from a nit comb?
The terms are used interchangeably here. FDA files lice combs under product code LJL, “Detectors And Removers, Lice, (Including Combs).”
What is a lice removal comb in FDA terms?
A Class I device under 21 CFR 880.5960, exempt from 510(k) premarket notification subject to the limitations in 21 CFR 880.9.
Sources
- 21 CFR 880.5960, Lice removal kit, Legal Information Institute: https://www.law.cornell.edu/cfr/text/21/880.5960 (checked 30 October 2026).
- openFDA device classification, product code LJL: https://api.fda.gov/device/classification.json?search=product_code:LJL (checked 30 October 2026; dataset updated 19 October 2026).
