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General product and regulatory information only, not medical advice and not infection-control policy for any facility.
Short answer: what is a surgical cap?
A surgical cap is a head covering worn by operating room personnel during surgery. In U.S. regulation it is a Class I medical device, product code FYF, named in 21 CFR 878.4040 (surgical apparel) and exempt from 510(k) premarket notification. Manufacturers must still register their establishments with FDA.
Definition and scope
21 CFR 878.4040(a) defines surgical apparel as devices intended to be worn by operating room personnel during surgical procedures to protect both the patient and operating room personnel from transfer of microorganisms, body fluids and particulate material. The regulation lists surgical caps among its examples, alongside hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Scrub suits are excluded from the definition.
The NLM AccessGUDID registry describes the generic device type in the same terms: GMDN term 32297, “Surgical cap, single-use”, a head covering worn by surgical staff to protect the patient and staff from microorganisms, body fluids and particulate material.
How surgical caps are regulated in practice
FDA’s product classification database lists the code FYF as “cap, surgical”: device class 1, regulation number 878.4040, 510(k) exempt. Under 21 CFR 878.4040(b), most surgical apparel is Class I under general controls, and exempt from premarket notification under 21 CFR 878.9. Only surgical gowns and surgical masks are placed in Class II with special controls.
Where a surgical cap sits among surgical apparel
| Item | Treatment in 21 CFR 878.4040 |
|---|---|
| Surgical cap | Named as surgical apparel; Class I (general controls); exempt from 510(k) |
| Surgical hood, operating room shoes and shoe covers | Named as surgical apparel; Class I (general controls) as “other surgical apparel” |
| Surgical gown, surgical mask | Class II with special controls |
| Scrub suit | Excluded from the surgical apparel definition |
Class I means general controls apply; a cap needs no premarket notification.
Surgical cap types
The regulation does not divide caps into subtypes. The registry shows how a product is recorded: a “Bouffant Cap” listing in AccessGUDID carries product code FYF and the single-use cap GMDN term, while the regulation lists a surgical hood as a separate item from a cap. Style names beyond that (for example bouffant versus close-fitting skull caps) are manufacturer and facility terms rather than FDA categories. For how the bouffant versus skull cap choice is argued in attire policy, see our guide on surgical bouffant caps and head covering requirements.
Where it matters for labs, clinics and supply decisions
Because registry records vary, a product record is worth reading rather than assuming. The AccessGUDID record for one white bouffant cap shows what to expect:
- Product code: FYF, “Cap, Surgical”.
- Sterility: the record states “Packaged as Sterile: No”; single-use: yes. Sterile status is declared per product, not implied by the device type.
- Latex: the record states the device is not made with natural rubber latex.
- Premarket status: exempt from premarket submission, consistent with the regulation.
- Size: the brand name says 24 inch while the description says 21 inch outside diameter, and the “Clinically Relevant Size” field reads “No Device Sizes”.
The practical reading: a facility comparing caps can check the FDA product code, the declared sterile and single-use status, the latex statement, and the size basis on each product’s own label or record. For related supply planning, see the ambulatory surgery center supply checklist, and for other items in the same regulation, surgical shoes and surgical masks. Surgical caps are one of many medical devices regulated by FDA.
Common misunderstandings
Surgical cap sizes: is there a standard?
No standard is set in the regulation or the registry. The registry record above shows a size field with no device sizes and a name and description that disagree (24 inch versus 21 inch), so the size on a product’s label is the manufacturer’s own and should be read per product.
“Class I means no regulation”
Class I devices are subject to general controls, and manufacturers of 510(k)-exempt devices must still register their establishments, per FDA’s classification entry for FYF.
“A surgical cap is the same as a scrub suit or a hood”
The regulation names caps and hoods separately and excludes scrub suits from surgical apparel altogether.
FAQ
What is a surgical cap?
A head covering worn by surgical staff during an operation, classified by FDA as a Class I, 510(k)-exempt device under 21 CFR 878.4040 (product code FYF).
What are the types of surgical caps?
FDA does not define subtypes. Hoods are listed as a separate surgical apparel item, and bouffant and other style names are manufacturer terms.
What are surgical cap sizes?
Sizes are set by each manufacturer; the registry does not standardize them, so read the label of each product.
Sources
- 21 CFR 878.4040, Surgical apparel, eCFR (ecfr.gov), checked 2026-10-30.
- FDA Product Classification database, product code FYF (accessdata.fda.gov), checked 2026-10-30.
- NLM AccessGUDID, Bouffant Cap record DI 00850037747245 (accessgudid.nlm.nih.gov), checked 2026-10-30.
