Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
“Eye patch” is an everyday name for several different products worn over the eye. The two that matter most to clinic staff and buyers are the eye pad, a soft gauze or cotton pad used as a bandage, and the eye shield, a rigid plastic or aluminum cover. FDA regulates both as separate Class I device types, with different definitions. This page maps the everyday names to those definitions.
Who uses them: eye clinics and surgery centers, emergency and first-aid settings, and the staff who stock them. For stock lists see the optometry clinic supply checklist and the ophthalmology surgery center supply checklist.
What is an eye patch?
There is no single product called an eye patch in FDA’s device regulations. The everyday term usually means one of two things: a soft pad that covers the eye as a bandage (FDA name: eye pad) or a rigid cover that protects the eye (FDA name: ophthalmic eye shield). The term is also used for coverings worn over one eye for other purposes; this page does not cover those, and a prescriber’s instructions govern their use.
Eye patch vs eye shield vs eye pad
Short answer: a pad is soft and absorbent; a shield is rigid and protective. 21 CFR 878.4440 defines an eye pad as “a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.” 21 CFR 886.4750 defines an ophthalmic eye shield as “a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.”
Because the two definitions differ, a product listing that says “eye patch” should be checked against the material and stated purpose: gauze or cotton for protection or absorption of secretions points to an eye pad, while a plastic or aluminum covering points to an eye shield. Follow the manufacturer’s instructions for use for any specific product.
Types and how FDA classifies them
| Everyday name | FDA device name and product code | Regulation | Class and exemption |
|---|---|---|---|
| Eye pad, gauze or cotton eye dressing | Pad, Eye (HMP) | 21 CFR 878.4440 | Class I. Exempt from premarket notification (510(k)), subject to 21 CFR 878.9. openFDA’s GMP-exempt flag for HMP is N. |
| Eye shield (ophthalmic), including post-mydriatic eyewear | Shield, Eye, Ophthalmic, including sunlamp protective eyewear and post-mydriatic eyewear (HOY) | 21 CFR 886.4750 | Class I. When made only of plastic or aluminum, exempt from 510(k) and from the quality management system requirements of part 820 except records and complaint files (820.35). |
| Neonatal eye pad | Pad, Neonatal Eye (FOK) | 21 CFR 880.5270 | Class I. Exempt from premarket notification, subject to 21 CFR 880.9. Defined as an opaque device used to cover and protect an infant’s eye during therapeutic procedures such as phototherapy. |
Source: 21 CFR text via Cornell LII and the openFDA device classification API, both checked 2026-10-30.
Not the same product: radiological eye shields
“Eye shield” also appears in radiation protection. openFDA lists “Shield, Eye, Radiological” (product code IWS) under 21 CFR 892.6500, a separate Class I device type from the ophthalmic shield above. Check which one a product description means.
Common mistakes
- Treating “eye shield” and “eye pad” as interchangeable. FDA defines the pad as an absorbent bandage and the shield as a rigid protective or dressing-retaining cover.
- Assuming a radiological eye shield and an ophthalmic eye shield are the same device type.
- Assuming every eye covering has the same regulatory status. The pad, the shield and the neonatal pad are separate entries with their own exemption wording.
FAQ
What is an eye patch?
An everyday name for a covering worn over the eye. In FDA’s device regulations the matching entries are the eye pad (gauze or cotton bandage) and the ophthalmic eye shield (plastic or aluminum cover).
What is the difference between an eye patch and an eye shield?
Judged by FDA’s definitions, a pad-style patch is a soft bandage for protection or absorption of secretions, while a shield is a rigid cover that protects the eye or holds dressing materials in place.
Sources
- 21 CFR 878.4440, Eye pad: https://www.law.cornell.edu/cfr/text/21/878.4440 (checked 2026-10-30)
- 21 CFR 886.4750, Ophthalmic eye shield: https://www.law.cornell.edu/cfr/text/21/886.4750 (checked 2026-10-30)
- openFDA device classification API: https://api.fda.gov/device/classification.json (checked 2026-10-30)
- 21 CFR 880.5270, Neonatal eye pad: https://www.law.cornell.edu/cfr/text/21/880.5270 (checked 2026-10-30)
Related: what are safety goggles and eyewash station inspection.
