QPC

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Product code

QPC

Device name

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Device class

Class 2

21 CFR

21 CFR 878.4040

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

11

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-08-11.

1 summaries are archived here for direct download.