DeviceClearance

Product code QPC— General, Plastic Surgery

AAMI Level 4 Protective; Gown

Classification name
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Total cleared
12
First cleared
Most recent

FDA classification definition

“A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.”

— U.S. Food and Drug Administration, device classification record for product code QPC under 21 CFR 878.4040, via openFDA

Market context for product code QPC

FDA has cleared 12 devices under product code QPC between 2017 and 2026, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QPC

Recent clearances under product code QPC

Data sourced from openFDA. This site is unofficial and independent of the FDA.