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 PolyConversions, Inc., Kenpax International Limited and Medline Industries, LP.

12
Total
12
Cleared
229d
Avg days
2017
Since
Growing category - 4 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 110d 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)

12 devices
1–12 of 12
Cleared Sep 11, 2026
PRIMED AAMI Level 3 Open Back Gowns
K262007
Primed Medical Products, Inc.
General Hospital · 88d
Cleared Aug 11, 2026
VR® Personal Protective Level 4 Gown (VR Gowns)
K261115
PolyConversions, Inc.
General Hospital · 130d
Cleared Dec 16, 2025
VR® Personal Protective Level 3 Gown (VR Gowns)
K252940
PolyConversions, Inc.
General Hospital · 92d
Cleared Jan 13, 2025
AAMI Level 4 Protective
K242689
Azac Group
General Hospital · 129d
Cleared Mar 05, 2024
Medline Open-back Level 3 Protective Gown
K233526
Medline Industries, LP
General Hospital · 125d
Cleared Aug 11, 2023
PolyWear® Personal Protective Level 3 Gown
K230384
PolyConversions, Inc.
General Hospital · 178d
Cleared Aug 08, 2023
Protective Gown AAMI Level 4
K222128
Kenpax International Limited
General Hospital · 386d
Cleared Mar 30, 2022
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
K212464
Dukal Corporation
General Hospital · 236d
Cleared Dec 17, 2021
Donagamex Blue Performance Protective Gown
K203821
Dong Nai Garment Corporation (Donagamex)
General Hospital · 353d
Cleared Dec 15, 2021
ProTEC-USA EZDoff Gown
K210405
Cadillac Products, Inc.
General Hospital · 308d
Cleared Apr 26, 2019
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
K182830
Cardinal Health200, LLC
General Hospital · 203d
Cleared Jul 07, 2017
Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
K160337
Bam Corporation Limited
General Hospital · 515d

About Product Code QPC - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code QPC since 2017, with 12 receiving FDA clearance (average review time: 229 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QPC Product Code

Recent submissions under QPC have taken an average of 110 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 →