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 PolyConversions, Inc., Cardinal Health200, LLC and Dong Nai Garment Corporation (Donagamex).
10
Total
10
Cleared
253d
Avg days
2017
Since
Declining activity -
2 submissions in the last 2 years
vs 3 in the prior period
Review times improving: avg
111d
recently vs 288d historically
FDA 510(k) Cleared Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection Devices (Product Code QPC)
10 devices
Cleared
Dec 16, 2025
VR® Personal Protective Level 3 Gown (VR Gowns)
PolyConversions, Inc.
General Hospital
92d
Cleared
Jan 13, 2025
AAMI Level 4 Protective
Azac Group
General Hospital
129d
Cleared
Mar 05, 2024
Medline Open-back Level 3 Protective Gown
Medline Industries, LP
General Hospital
125d
Cleared
Aug 11, 2023
PolyWear® Personal Protective Level 3 Gown
PolyConversions, Inc.
General Hospital
178d
Cleared
Aug 08, 2023
Protective Gown AAMI Level 4
Kenpax International Limited
General Hospital
386d
Cleared
Mar 30, 2022
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
Dukal Corporation
General Hospital
236d
Cleared
Dec 17, 2021
Donagamex Blue Performance Protective Gown
Dong Nai Garment Corporation (Donagamex)
General Hospital
353d
Cleared
Dec 15, 2021
ProTEC-USA EZDoff Gown
Cadillac Products, Inc.
General Hospital
308d
Cleared
Apr 26, 2019
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
Cardinal Health200, LLC
General Hospital
203d
About Product Code QPC - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code QPC since 2017, with 10 receiving FDA clearance (average review time: 253 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - QPC Product Code
Recent submissions under QPC have taken an average of 111 days to reach a decision - down from 288 days historically, suggesting improved FDA processing for this classification.
QPC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →