FDA product code QPC: Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
QPC is the FDA product code for gown, non-sterile, non-isolation, intended to provide moderate or high barrier protection. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 12 510(k) submissions under QPC, 8 in the last five years, from 10 different applicants. The average 510(k) review took 229 days (median 190); 115 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QPC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 515 |
| 2019 | 1 | 203 |
| 2021 | 2 | 330 |
| 2022 | 1 | 236 |
| 2023 | 2 | 282 |
| 2024 | 1 | 125 |
| 2025 | 2 | 110 |
| 2026 | 2 | 109 |
Compare with all 510(k) review times · Search every QPC clearance
Top QPC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| PolyConversions, Inc. | 3 | 2026-08-11 |
| PRIMED Medical Products, Inc. | 1 | 2026-09-11 |
| Azac Group | 1 | 2025-01-13 |
| Medline Industries, LP | 1 | 2024-03-05 |
| Kenpax International Limited | 1 | 2023-08-08 |
5 more applicants have QPC clearances. See the full list in Caduvo.
Most recent QPC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262007 | PRIMED Medical Products, Inc. | PRIMED AAMI Level 3 Open Back Gowns | 2026-09-11 | 88 |
| K261115 | PolyConversions, Inc. | VR® Personal Protective Level 4 Gown (VR Gowns) | 2026-08-11 | 130 |
| K252940 | PolyConversions, Inc. | VR® Personal Protective Level 3 Gown (VR Gowns) | 2025-12-16 | 92 |
| K242689 | Azac Group | AAMI Level 4 Protective; Gown | 2025-01-13 | 129 |
| K233526 | Medline Industries, LP | Medline Open-back Level 3 Protective Gown | 2024-03-05 | 125 |
Recalls for QPC devices
openFDA lists no recalls for product code QPC.
Frequently asked questions
What is FDA product code QPC?
QPC is the FDA product code for gown, non-sterile, non-isolation, intended to provide moderate or high barrier protection. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is QPC?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPC?
Across 12 cleared submissions the average was 229 days from receipt to decision (median 190).
Which companies have the most QPC clearances?
PolyConversions, Inc. (3); PRIMED Medical Products, Inc. (1); Azac Group (1); Medline Industries, LP (1); Kenpax International Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QPC
- Run a recall and safety report across every QPC manufacturer
- Watch product code QPC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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