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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Who uses it: care-home and clinic staff, home-care buyers and students who need to tell bed-protection products apart from worn incontinence products before buying.
What bed pads are in an incontinence supply range
An incontinence supply range usually mixes three different product classes: pads that lie on the bed, covers that protect the mattress, and absorbent products that are worn on the body. In US federal regulation, bed pads sit under “medical disposable bedding”: a device intended to be used by one patient for a period of time and then discarded, which the regulation says may include disposable bedsheets, bedpads, pillows and pillowcases, blankets and waterproof sheets (21 CFR 880.6060, checked 2026-11-03). The CASRAI guide to underpads covers the product itself in more detail.
Bed pads vs mattress covers vs worn products
The table shows how FDA classifies each layer. Every row comes from the CFR section and the FDA product classification record named in the table (both checked 2026-11-03).
| Layer | FDA product code and name | Regulation and class | What the regulation says it is |
|---|---|---|---|
| Bed pad (disposable bedding) | KME, Bedding, Disposable, Medical | 21 CFR 880.6060, Class I | Used by one patient for a period of time, then discarded; may include bedpads and waterproof sheets |
| Mattress cover | FMW, Cover, Mattress (Medical Purposes) | 21 CFR 880.6190, Class I | Used to protect a mattress; may be electrically conductive or contain a germicide |
| Worn protective garment | EYQ, Garment, Protective, For Incontinence | 21 CFR 876.5920, Class I | Absorbent padding and a fluid barrier, intended to protect an incontinent patient’s garment from the patient’s excreta; does not include infant diapers |
Related CASRAI guides: waterproof mattress covers and body-worn disposable incontinence pads.
Disposable and reusable bed pads
The disposable bedding regulation (21 CFR 880.6060) describes a device used by one patient for a period of time and then discarded. The regulation does not set absorbency, layer construction or wash life for bed pads; those values come from each manufacturer’s labeling, so the product code and class for a reusable or washable pad should be taken from that labeling rather than from the product name.
What to verify on a product listing
- Which class the listing belongs to. Check whether the product is a bed pad, a mattress cover or a worn garment, using the table above. The three sit under different regulations.
- Sterile or non-sterile labeling. For bed pads and mattress covers, the exemption from the quality management system regulation (part 820) applies only if the device is not labeled or otherwise represented as sterile, and even then records and complaint files (21 CFR 820.35) still apply (880.6060 and 880.6190).
- Size and absorbency. Ask for the manufacturer’s labeling or instructions; the CFR definitions do not set sizes or absorbency.
- What “FDA” wording means. All three classes are Class I and exempt from premarket notification (510(k)) subject to the limits in 21 CFR 880.9 or 876.9. A listing that implies a premarket review for these products is not describing something the regulation requires.
For worn products and range planning, see the adult incontinence product selection guide and incontinence supplies for elderly care. Listings in a supplier’s catalogue, such as incontinence supplies, can be compared against the table above.
Common mistakes
- Treating a mattress cover as a bed pad. They are separate product codes with different regulatory definitions (FMW and KME).
- Treating a bed pad as a worn product. A protective garment for incontinence (EYQ) is defined by its job of protecting the patient’s garment, not the bed.
- Reading “FDA approved” or “FDA certified” in a listing as proof of quality. For these Class I, 510(k)-exempt devices, the regulation does not require premarket review.
FAQ
What are incontinence bed pads?
Under 21 CFR 880.6060 they fall under medical disposable bedding, a device intended for one patient for a period of time and then discarded, with bedpads named as an example (checked 2026-11-03).
Are bed pads and mattress covers the same thing?
No. FDA lists them under different product codes and regulations: KME and 21 CFR 880.6060 for disposable bedding, FMW and 21 CFR 880.6190 for mattress covers.
Do bed pads need FDA 510(k) clearance?
Medical disposable bedding is Class I and exempt from premarket notification subject to 21 CFR 880.9 (21 CFR 880.6060, checked 2026-11-03).
Sources
- 21 CFR 880.6060, Medical disposable bedding (eCFR, checked 2026-11-03)
- 21 CFR 880.6190, Mattress cover for medical purposes (eCFR, checked 2026-11-03)
- 21 CFR 876.5920, Protective garment for incontinence (eCFR, checked 2026-11-03)
- openFDA device classification, product codes KME, FMW and EYQ (checked 2026-11-03)
