QPC · Class II · 21 CFR 878.4040

FDA Product Code QPC: Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection

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.

Leading manufacturers include Medline Industries, LP.

1
Total
1
Cleared
125d
Avg days
2024
Since

List of Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection devices (product code QPC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →