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This page describes products and general use; it is not medical advice.
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A waterproof mattress cover for incontinence care is a fitted, protective layer whose job is to keep body fluids from reaching the mattress. Two official sources decide most of what a buyer or clinic needs to check: the FDA classification of medical mattress covers and the CDC’s rules on when covers and mattresses must be replaced. Both are summarised below. The page is for clinic staff, care-facility buyers and students who need to know what to verify and what to request from a supplier; it does not rank products or quote prices.
What a waterproof mattress cover for incontinence is
The CDC’s environmental infection control guideline describes a mattress cover as “generally a fitted, protective material, the purpose of which is to prevent the mattress from becoming contaminated with body fluids and substances.” Under 21 CFR 880.6190, the FDA defines a mattress cover for medical purposes as “a device intended for medical purposes that is used to protect a mattress,” and adds that it may be electrically conductive or contain a germicide.
Who uses it: health-care facilities and care settings where a mattress needs protection from body fluids. For the vinyl variant and its care rules see vinyl mattress covers; for mattress sizes see hospital bed mattress dimensions.
Cover, underpad, disposable bedding or linen sheet
These items are often grouped together in product listings but are different things in the regulatory record. The CDC states that a linen sheet placed on a mattress is not considered a mattress cover.
| Item | What the record says | Source |
|---|---|---|
| Mattress cover for medical purposes | FDA product code FMW; 21 CFR 880.6190; Class I (general controls); exempt from premarket notification | 21 CFR 880.6190 |
| Reusable absorbent underpad | An AccessGUDID record lists GMDN term 66117, “Absorbent underpad, non-antimicrobial, reusable,” with product code FMW and no sterile labeling | AccessGUDID device 00634916081404 |
| Disposable bedding (bedsheets, bedpads, waterproof sheets) | FDA product code KME, “bedding, disposable, medical”; 21 CFR 880.6060; Class 1; 510(k) exempt | 21 CFR 880.6060 |
| Linen sheet | Not considered a mattress cover | CDC Environmental Infection Control Guidelines |
For underpads in more depth, see what are underpads; for single-use pads, see disposable incontinence pads.
What FDA classification does and does not tell you
Medical mattress covers are Class I devices under general controls and are exempt from premarket notification (510(k)) under 21 CFR 880.6190, subject to the limits in 21 CFR 880.9. Unless a cover is labeled or represented as sterile, it is also exempt from the quality management system requirements of part 820, except for requirements concerning records and complaint files under 21 CFR 820.35. In practice this means the Class I status describes the regulatory category; it is not a measure of how well a particular product performs. That is why the documents a supplier provides matter (see below).
When to replace a cover or mattress (CDC)
The CDC guideline, written for health-care facilities, gives these points:
- Standard mattresses can become contaminated with body substances if the integrity of the cover is compromised.
- Patches for tears and holes in mattress covers do not provide an impermeable surface over the mattress.
- Mattress covers should be replaced when torn; the mattress should be replaced if it is visibly stained.
- Wet mattresses can be a substantial environmental source of microorganisms; the guideline notes that removing wet mattresses was an effective control measure in reported outbreaks involving burn patients.
- Covers and pads were cleaned and disinfected between patients using disinfectant products compatible with the cover material, so that the covers remained impermeable to fluids.
These are facility guidelines and should not be read as a home-use rule. For how mattresses fit into bed systems, see hospital bed mattresses.
Documents to request from a supplier
A procurement checklist built from the sources above can ask for:
- The manufacturer’s instructions for use or care label, including which disinfectants the cover material is compatible with (the CDC’s concern is that covers stay impermeable after disinfection).
- The FDA classification the supplier relies on (for example product code FMW and 21 CFR 880.6190 for a mattress cover).
- The mattress dimensions the cover is intended to fit; see hospital bed mattress dimensions.
Common mistakes
- Treating a linen sheet as a mattress cover. The CDC says it is not one.
- Patching a torn cover. The CDC says patches do not restore an impermeable surface.
- Keeping a mattress that is visibly stained. The CDC says the mattress should be replaced.
- Reading Class I or 510(k)-exempt status as a quality endorsement. It is a regulatory category.
Frequently asked questions
Is a waterproof mattress cover a medical device?
When it is intended for medical purposes to protect a mattress, yes: the FDA regulates it as a Class I device under 21 CFR 880.6190.
Can I patch a torn mattress cover?
The CDC states that patches do not provide an impermeable surface and that torn covers should be replaced.
Is a waterproof sheet the same as a mattress cover?
Not in the CDC’s wording, which says a linen sheet is not a mattress cover. Disposable waterproof sheets and bedpads have their own FDA code (KME, 21 CFR 880.6060). See also adult incontinence product selection.
Sources
- FDA / eCFR, 21 CFR 880.6190, Mattress cover for medical purposes, https://www.ecfr.gov/current/title-21/section-880.6190 (checked 2026-11-02).
- CDC, Guidelines for Environmental Infection Control in Health-Care Facilities (2003, last update July 2019), section on standard mattresses, pillows and air-fluidized beds, https://www.cdc.gov/infection-control/media/pdfs/Guideline-Environmental-H.pdf (checked 2026-11-02).
- NLM AccessGUDID, device 00634916081404, https://accessgudid.nlm.nih.gov/devices/00634916081404 (checked 2026-11-02).
- FDA / eCFR, 21 CFR 880.6060, Medical disposable bedding (product code KME), https://www.ecfr.gov/current/title-21/section-880.6060 (checked 2026-11-02).
